Physiological and environmental monitoring methods

ABSTRACT

Systems and methods for monitoring various physiological and environmental factors, as well as systems and methods for using this information for a plurality of useful purposes, are provided. Real-time, noninvasive health and environmental monitors include a plurality of compact sensors integrated within small, low-profile devices. Physiological and environmental data is collected and wirelessly transmitted into a wireless network, where the data is stored and/or processed. This information is then used to support a variety of useful methods, such as clinical trials, marketing studies, biofeedback, entertainment, and others.

RELATED APPLICATIONS

This application is a continuation application of pending U.S. patentapplication Ser. No. 11/848,878, filed Aug. 31, 2007, which claims thebenefit of and priority to U.S. Provisional Patent Application No.60/905,761, filed Mar. 8, 2007, U.S. Provisional Patent Application No.60/876,128, filed Dec. 21, 2006, and U.S. Provisional Patent ApplicationNo. 60/875,606, filed Dec. 19, 2006, the disclosures of which areincorporated herein by reference as if set forth in their entireties.

FIELD OF THE INVENTION

The present invention relates generally to health and, moreparticularly, to health monitoring.

BACKGROUND

There is growing market demand for personal health and environmentalmonitors, for example, for gauging overall health and metabolism duringexercise, athletic training, dieting, and physical therapy. However,traditional health monitors and environmental monitors may be bulky,rigid, and uncomfortable—generally not suitable for use during dailyphysical activity. There is also growing interest in generating andcomparing health and environmental exposure statistics of the generalpublic and particular demographic groups. For example, collectivestatistics enable the healthcare industry and medical community todirect healthcare resources to where they are most highly valued.However, methods of collecting these statistics may be expensive andlaborious, often utilizing human-based recording/analysis steps atmultiple sites.

SUMMARY

In view of the above discussion, systems and methods for monitoringvarious physiological and environmental factors, as well as systems andmethods for using this information for a plurality of useful purposes,are provided. According to some embodiments of the present invention,real-time, noninvasive health and environmental monitors include aplurality of compact sensors integrated within small, low-profiledevices. Physiological and environmental data is collected andwirelessly transmitted into a wireless network, where the data is storedand/or processed. This information is then used to support a variety ofuseful methods, such as clinical trials, marketing studies, biofeedback,entertainment, and others.

Though the methods herein may apply broadly to a variety of form factorsfor a monitoring apparatus, in some embodiments of the invention anearpiece functions as a physiological monitor, an environmental monitor,and a wireless personal communicator. Because the ear region is locatednext to a variety of “hot spots” for physiological an environmentalsensing—including the tympanic membrane, the carotid artery, theparanasal sinus, etc.—in some cases an earpiece monitor takes preferenceover other form factors. The earpiece can take advantage of commerciallyavailable open-architecture, ad hoc, wireless paradigms, such asBluetooth®, Wi-Fi, or ZigBee. In some embodiments, a small, compactearpiece contains at least one microphone and one speaker, and isconfigured to transmit information wirelessly to a recording device suchas, for example, a cell phone, a personal digital assistant (PDA),and/or a computer. The earpiece contains a plurality of sensors formonitoring personal health and environmental exposure. Health andenvironmental information, sensed by the sensors is transmittedwirelessly, in real-time, to a recording device, capable of processingand organizing the data into meaningful displays, such as charts. Insome embodiments, an earpiece user can monitor health and environmentalexposure data in real-time, and may also access records of collecteddata throughout the day, week, month, etc., by observing charts and datathrough an audio-visual display.

Each physiological sensor is configured to detect and/or measure one ormore of the following types of physiological information: heart rate,pulse rate, breathing rate, blood flow, heartbeat signatures,cardio-pulmonary health, organ health, metabolism, electrolyte typeand/or concentration, physical activity, caloric intake, caloricmetabolism, blood metabolite levels or ratios, blood pH level, physicaland/or psychological stress levels and/or stress level indicators, drugdosage and/or dosimetry, physiological drug reactions, drug chemistry,biochemistry, position and/or balance, body strain, neurologicalfunctioning, brain activity, brain waves, blood pressure, cranialpressure, hydration level, auscultatory information, auscultatorysignals associated with pregnancy, physiological response to infection,skin and/or core body temperature, eye muscle movement, blood volume,inhaled and/or exhaled breath volume, physical exertion, exhaled breathphysical and/or chemical composition, the presence and/or identityand/or concentration of viruses and/or bacteria, foreign matter in thebody, internal toxins, heavy metals in the body, anxiety, fertility,ovulation, sex hormones, psychological mood, sleep patterns, hungerand/or thirst, hormone type and/or concentration, cholesterol, lipids,blood panel, bone density, organ and/or body weight, reflex response,sexual arousal, mental and/or physical alertness, sleepiness,auscultatory information, response to external stimuli, swallowingvolume, swallowing rate, sickness, voice characteristics, voice tone,voice pitch, voice volume, vital signs, head tilt, allergic reactions,inflammation response, auto-immune response, mutagenic response, DNA,proteins, protein levels in the blood, water content of the blood,pheromones, internal body sounds, digestive system functioning, cellularregeneration response, healing response, stem cell regenerationresponse, and/or other physiological information.

Each environmental sensor is configured to detect and/or measure one ormore of the following types of environmental information: climate,humidity, temperature, pressure, barometric pressure, soot density,airborne particle density, airborne particle size, airborne particleshape, airborne particle identity, volatile organic chemicals (VOCs),hydrocarbons, polycyclic aromatic hydrocarbons (PAHs), carcinogens,toxins, electromagnetic energy, optical radiation, X-rays, gamma rays,microwave radiation, terahertz radiation, ultraviolet radiation,infrared radiation, radio waves, atomic energy alpha particles, atomicenergy beta-particles, gravity, light intensity, light frequency, lightflicker, light phase, ozone, carbon monoxide, carbon dioxide, nitrousoxide, sulfides, airborne pollution, foreign material in the air,viruses, bacteria, signatures from chemical weapons, wind, airturbulence, sound and/or acoustical energy, ultrasonic energy, noisepollution, human voices, animal sounds, diseases expelled from others,exhaled breath and/or breath constituents of others, toxins from others,pheromones from others, industrial and/or transportation sounds,allergens, animal hair, pollen, exhaust from engines, vapors and/orfumes, fuel, signatures for mineral deposits and/or oil deposits, snow,rain, thermal energy, hot surfaces, hot gases, solar energy, hail, ice,vibrations, traffic, the number of people in a vicinity of the person,coughing and/or sneezing sounds from people in the vicinity of theperson, loudness and/or pitch from those speaking in the vicinity of theperson, and/or other environmental information.

In some embodiments, the signal processor is configured to processsignals produced by the physiological and environmental sensors intosignals that can be heard and/or viewed by the person wearing theapparatus. In some embodiments, the signal processor is configured toselectively extract environmental effects from signals produced by aphysiological sensor and/or selectively extract physiological effectsfrom signals produced by an environmental sensor.

A monitoring system, according to some embodiments of the presentinvention, may be configured to detect damage to a portion of the bodyof the person wearing the apparatus, and may be configured to alert theperson when such damage is detected. For example, when a person isexposed to sound above a certain level that may be potentially damaging,the person is notified by the apparatus to move away from the noisesource. As another example, the person may be alerted upon damage to thetympanic membrane due to loud external noises.

Information from the health and environmental monitoring system may beused to support a clinical trial and/or study, marketing study, dietingplan, health study, wellness plan and/or study, sickness and/or diseasestudy, environmental exposure study, weather study, traffic study,behavioral and/or psychosocial study, genetic study, a health and/orwellness advisory, and an environmental advisory. The monitoring systemmay be used to support interpersonal relationships between individualsor groups of individuals. The monitoring system may be used to supporttargeted advertisements, links, searches or the like through traditionalmedia, the internet, or other communication networks. The monitoringsystem may be integrated into a form of entertainments, such as healthand wellness competitions, sports, or games based on health and/orenvironmental information associated with a user.

According to some embodiments of the present invention, a method ofmonitoring the health of one or more subjects includes receivingphysiological and/or environmental information from each subject viarespective portable monitoring devices associated with each subject, andanalyzing the received information to identify and/or predict one ormore health and/or environmental issues associated with the subjects.Each monitoring device has at least one physiological sensor and/orenvironmental sensor. Each physiological sensor is configured to detectand/or measure physiological information from the subject, and eachenvironmental sensor is configured to detect and/or measureenvironmental conditions in a vicinity of the subject. The physiologicalinformation and/or environmental information may be analyzed locally viathe monitoring device or may be transmitted to a location geographicallyremote from the subject for analysis. The collected information mayundergo virtually any type of analysis. In some embodiments, thereceived information may be analyzed to identify and/or predict theaging rate of the subjects, to identify and/or predict environmentalchanges in the vicinity of the subjects, and to identify and/or predictpsychological and/or physiological stress for the subjects.

According to some embodiments of the present invention, correctiveaction information may be communicated to the subjects in response toidentifying one or more health and/or environmental problems associatedwith the subject. In addition or alternatively, corrective actioninformation for the subjects may be communicated to third parties.

In some embodiments, a geographical map illustrating health-relatedand/or environmental conditions associated with the subjects may becreated.

According to some embodiments of the present invention, a health andenvironmental monitoring system includes a plurality of portablemonitoring devices, each comprising at least one physiological sensorand/or environmental sensor, a plurality of portable communicationdevices, wherein each communication device is in communication with arespective monitoring device and is configured to transmit data from themonitoring device to remote data storage, and a processor configured toanalyze data within the remote data storage and to identify and/orpredict health and/or environmental issues associated with each subject.Each physiological sensor is configured to detect and/or measurephysiological information from a respective subject, and eachenvironmental sensor is configured to detect and/or measureenvironmental conditions in a vicinity of the respective subject. Eachmonitoring device is configured to be worn by a respective subject(e.g., attached to a body of a respective subject, etc.). For example, amonitoring device may be configured to be attached to an ear of arespective subject.

In some embodiments, the processor is configured to communicatecorrective action information to each respective subject. Correctiveaction information may be communicated to each subject via themonitoring device associated with each respective subject, or via othermethods.

In other embodiments, the processor communicates corrective actioninformation for a subject to a third party. The processor may beconfigured to perform various analyses including, but not limited to,identifying and/or predicting the aging rate of one or more subjects,identifying and/or predicting environmental changes in the vicinity ofone or more subjects, and identifying and/or predicting psychologicaland/or physiological stress for one or more subjects. In someembodiments of the present invention, the processor is configured tocreate a geographical map illustrating health and/or environmentalconditions associated with one or more subjects.

Information collected from each monitoring device may includeinformation that is personal and private and information that can bemade available to the public. As such, data storage, according to someembodiments of the present invention, may include a private portion anda public portion. In the private portion, health and environmental datathat is personalized for each subject is stored. In the public portion,anonymous health and environmental data is stored and is accessible bythird parties.

In other embodiments of the present invention, a method of deliveringtargeted advertising to a person includes collecting physiologicaland/or environmental information from the person, selecting anadvertisement for delivery to the person based upon the collectedphysiological and/or environmental information, and delivering theselected advertisement to the person. The physiological and/orenvironmental information is collected via a monitoring deviceassociated with the person and that includes at least one physiologicalsensor and/or environmental sensor, as described above. The receivedphysiological and/or environmental information is analyzed to identify aphysiological condition of the person and/or environmental condition ina vicinity of the person, and an advertisement is selected for a productor service related to an identified physiological and/or environmentalcondition. The selected advertisement can be delivered via any ofvarious channels including, but not limited to, email, postal mail,television, radio, newspaper, magazine, the internet, and outdooradvertising.

According to some embodiments of the present invention, a system fordelivering targeted advertising to people includes a plurality ofportable monitoring devices, each comprising at least one physiologicalsensor and/or environmental sensor, as described above, and a remotelylocated advertisement selection device that receives physiologicaland/or environmental information from the monitoring devices, selectsadvertisements based upon the collected physiological and/orenvironmental information, and delivers selected advertisements to themonitored persons. The advertisement selection device receivesphysiological and/or environmental information from each monitoringdevice via a communication device (e.g., PDA, cell phone, laptopcomputer, etc.) associated with each respective monitoring device. Insome embodiments, the advertisement selection device is configured toselect an advertisement for a product and/or service related to aphysiological condition of a person and/or for a product and/or servicerelated to an environmental condition in a vicinity of a person.

In some embodiments, the advertisement selection device includes an adserver configured to deliver online advertisements. In otherembodiments, the advertisement selection device includes an email serverconfigured to deliver advertisements via email. In some embodiments, theadvertisement selection device is configured to communicate with a thirdparty service that can deliver selected advertisements via one or moreof the following delivery channels: postal mail, television, radio,newspaper, magazine, the internet, and outdoor advertising.

According to some embodiments of the present invention, a method ofsupporting interpersonal relationships includes collecting physiologicaland/or environmental information from a monitoring device associatedwith a first person when the first person is in the presence of a secondperson, determining a stress level of the first person using thecollected physiological and/or environmental information, and displayingthe stress level to the first person. The monitoring device includes atleast one physiological sensor and/or environmental sensor, as describedabove, and is configured to collect physiological and/or environmentalinformation that includes indicators associated with stress experiencedby the first person. The stress level of the first person may also becommunicated to one or more third parties.

In some embodiments, the physiological and/or environmental informationcollected from the first person is analyzed to identify a source ofstress. A solution for reducing stress also may be recommended to thefirst person. In some embodiments, the monitoring device can identifythe second person.

According to some embodiments of the present invention, a system forsupporting interpersonal relationships includes a portable monitoringdevice that collects physiological and/or environmental information froma first person when the first person is in the presence of a secondperson, and a processor that receives physiological and/or environmentalinformation from the monitoring device. The processor determines astress level of the first person using the collected physiologicaland/or environmental information, and transmits and/or displays thestress level to the first person. In some embodiments, the processorreceives physiological and/or environmental information from themonitoring device via a communication device (e.g., PDA, cell phone,laptop computer, etc.) associated with the monitoring device. Theprocessor may be configured to analyze the information and identify asource of stress. The processor may be configured to recommend solutionsfor reducing stress.

In another embodiment of the present invention, a method of supportinginterpersonal relationships includes collecting physiological and/orenvironmental information from a monitoring device associated with afirst person, and determining a mood of the first person using thecollected physiological and/or environmental information. The collectedinformation includes indicators associated with one or more moods of thefirst person. The mood of the first person may be communicated to asecond person, for example, via a communication network (e.g., textmessage, email, voice message, etc.).

A system for supporting interpersonal relationships, according to otherembodiments of the present invention, includes a portable monitoringdevice that collects physiological and/or environmental information froma first person, and a processor that receives physiological and/orenvironmental information from the monitoring device, and determines amood of the first person using the collected physiological and/orenvironmental information. The processor receives physiological and/orenvironmental information from the monitoring device via a communicationdevice (e.g., PDA, cell phone, laptop computer, etc.) associated withthe monitoring device. The processor is configured to communicate themood of the first person to a second person, for example, via acommunication network (e.g., text message, email, voice message, etc.).

According to further embodiments of the present invention, a method ofmonitoring one or more subjects includes collecting physiological and/orenvironmental information from a monitoring device associated with eachrespective subject, storing the collected physiological and/orenvironmental information at a remote storage device, and comparing thestored physiological and/or environmental information with benchmarkphysiological and/or environmental information to identify at least onebehavioral response of the one or more subjects. Behavioral responsesmay include, but are not limited to, behavioral responses to a productand/or service, behavioral responses to product and/or servicemarketing, behavioral responses to medical treatment, behavioralresponses to a drug, etc.

According to some embodiments of the present invention, a system formonitoring one or more subjects includes a plurality of portablemonitoring devices configured to collect physiological information froma subject and environmental condition information in a vicinity of asubject, as described above, and a processor that compares collectedphysiological and/or environmental information with benchmarkphysiological and/or environmental information to identify at least onebehavioral response of the one or more subjects. As described above,behavioral responses may include, but are not limited to, behavioralresponses to a product and/or service, behavioral responses to productand/or service marketing, behavioral responses to medical treatment,behavioral responses to a drug, etc. In some embodiments, a monitoringdevice may include a dosimeter configured to measure a dose of a drugtaken by a respective subject.

According to further embodiments of the present invention, a method ofmonitoring patients, includes collecting physiological and/orenvironmental information from each patient via a monitoring deviceassociated with each respective patient, and analyzing the collectedinformation to determine caloric intake, health, and physical activityof each patient.

According to further embodiments of the present invention, anentertainment system includes a gaming device, and a plurality ofportable, monitoring devices in communication with the gaming device,wherein each monitoring apparatus is associated with a game participantand is configured to transmit participant physiological informationand/or environmental information wirelessly to the gaming device. Thegaming device is configured to integrate into the gaming strategyphysiological information and/or environmental information received fromeach monitoring apparatus. Each monitoring apparatus includes at leastone physiological sensor and/or environmental sensor, as describedabove.

According to further embodiments of the present invention, a method ofinteracting with an electronic game includes collecting physiologicaland/or environmental information from a monitoring device associatedwith a person, analyzing the collected information to identify one ormore health and/or environmental issues associated with the person,sending the identified one or more health and/or environmental issues toa gaming device, and incorporating the identified one or more healthand/or environmental issues into a strategy of a game executing on thegaming device. The monitoring device includes at least one physiologicalsensor and/or environmental sensor, as described above.

In some embodiments, a gaming character may be created based on theperson using the identified one or more health and/or environmentalissues. In other embodiments, biofeedback may be provided to the personfor improving at least one skill associated with the electronic game.

According to further embodiments of the present invention, a method ofmonitoring a participant in an activity includes collectingphysiological and/or environmental information from a monitoring deviceassociated with the participant, analyzing the collected physiologicaland/or environmental information to identify one or more health-relatedand/or environmental issues associated with the participant, andproviding feedback to the participant, wherein the feedback is relevantto a skill utilized by the participant in the activity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a telemetric monitoring device forphysiological and/or environmental monitoring and personalcommunication, according to some embodiments of the present invention.

FIG. 2 is a block diagram of a telemetric network for health andenvironmental monitoring through portable telemetric monitoring devices,such as the device of FIG. 1, according to some embodiments of thepresent invention.

FIG. 3 illustrates a graphical user interface for displaying data,according to some embodiments of the present invention.

FIG. 4 illustrates an earpiece module according to some embodiments ofthe present invention.

FIGS. 5A-5B illustrates an earpiece module with an adjustable mouthpiecefor monitoring physiological and environmental information near themouth, according to some embodiments of the present invention, whereinFIG. 5A illustrates the mouthpiece in a stored position and wherein FIG.5B illustrates the mouthpiece in an extended operative position.

FIG. 6 illustrates an earpiece module incorporating variousphysiological and environmental sensors, according to some embodimentsof the present invention, and being worn by a user.

FIG. 7 illustrates an earpiece module according to other embodiments ofthe present invention that includes a temple module for physiologicaland environmental monitoring.

FIG. 8 illustrates a monitoring device having a plurality of health andenvironmental sensors and mounted onto a Bluetooth® headset module,according to some embodiments of the present invention.

FIG. 9 illustrates the display of physiological and environmentalinformation collected by a monitoring device, according to someembodiments of the present invention.

FIG. 10 illustrates the display of demographic comparisons ofphysiological and environmental information, according to someembodiments of the present invention.

FIG. 11 illustrates the display of stress level over time as measured bya monitoring device, according to some embodiments of the presentinvention.

FIG. 12 illustrates the display of a healthy/stress map, according tosome embodiments of the present invention.

DETAILED DESCRIPTION

The present invention now is described more fully hereinafter withreference to the accompanying drawings, in which preferred embodimentsof the invention are shown. This invention, however, may be embodied inmany different forms and should not be construed as limited to theembodiments set forth herein; rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

Like numbers refer to like elements throughout. In the figures, thesizes of certain lines, layers, components, elements or features may beexaggerated for clarity.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, steps, operations, elements, components, and/or groupsthereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the specification andrelevant art and should not be interpreted in an idealized or overlyformal sense unless expressly so defined herein. Well-known functions orconstructions may not be described in detail for brevity and/or clarity.

It will be understood that when an element is referred to as being “on”,“attached” to, “connected” to, “coupled” with, “contacting”, etc.,another element, it can be directly on, attached to, connected to,coupled with or contacting the other element or intervening elements mayalso be present. In contrast, when an element is referred to as being,for example, “directly on”, “directly attached” to, “directly connected”to, “directly coupled” with or “directly contacting” another element,there are no intervening elements present. It will also be appreciatedby those of skill in the art that references to a structure or featurethat is disposed “adjacent” another feature may have portions thatoverlap or underlie the adjacent feature.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of a device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of “over” and “under”. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

The term “earpiece module” includes any type of device that may beattached to or near the ear of a user and may have variousconfigurations, without limitation.

The term “real-time” is used to describe a process of sensing,processing, or transmitting information in a time frame which is equalto or shorter than the minimum timescale at which the information isneeded. For example, the real-time monitoring of pulse rate may resultin a single average pulse-rate measurement every minute, averaged over30 seconds, because an instantaneous pulse rate is often useless to theend user. Typically, averaged physiological and environmentalinformation is more relevant than instantaneous changes. Thus, in thecontext of the present invention, signals may sometimes be processedover several seconds, or even minutes, in order to generate a“real-time” response.

The term “monitoring” refers to the act of measuring, quantifying,qualifying, estimating, sensing, calculating, interpolating,extrapolating, inferring, deducing, or any combination of these actions.More generally, “monitoring” refers to a way of getting information viaone or more sensing elements. For example, “blood health monitoring”includes monitoring blood gas levels, blood hydration, andmetabolite/electrolyte levels.

The term “physiological” refers to matter or energy of or from the bodyof a creature (e.g., humans, animals, etc.). In embodiments of thepresent invention, the term “physiological” is intended to be usedbroadly, covering both physical and psychological matter and energy ofor from the body of an organism. However, in some cases, the term“psychological” is called-out separately to emphasize aspects ofphysiology that are more closely tied to conscious or subconscious brainactivity rather than the activity of other organs, tissues, or cells.

The term “psychosocial stress” refers to events of psychological orsocial origin which challenge the homeostatic state of biologicalsystems.

The term “body” refers to the body of a person (or animal) that mayutilize an earpiece module according to embodiments of the presentinvention. Monitoring apparatus, according to embodiments of the presentinvention may be worn by humans and animals.

The term “health” refers generally to the quality or quantity of one ormore physiological parameters with reference to an organism's functionalabilities.

The term “ad hoc” refers generally to a wireless connection establishedfor the duration of one session without the need for a base station.Instead, devices discover others within range to form a network.Bluetooth®, Zigbee, and Wi-Fi protocols are a few examples.

The term “processor” refers to a device that takes one form ofinformation and converts this information into another form, typicallyhaving more usefulness than the original form. For example, in thisinvention, a Bluecore processor may collect raw physiological orenvironmental data from various sensors and process this data into ameaningful assessment, such as pulse rate, blood pressure, or airquality. A variety of microprocessors or other processors may be usedherein.

The term “clinical study” refers broadly to the application of scienceto health, where “health” may refer to both physical health as well asmental or psychological health. The term “clinical study” and “clinicaltrial” are used interchangeably herein. As an example, the interactionbetween a therapy and health or physiology—such as a drug therapy,exercise/diet plan, physical regime, etc.—can constitute a clinicalstudy. As another example, the interaction between the health and theenvironmental exposure of individuals or groups can constitute aclinical study. In some cases a clinical study is performed byprofessionals in medicine or science. In other cases, a clinical studyis performed by amateurs, computer programs, or individuals themselves,sometimes in the form of self help.

The term “marketing” refers to the act of bringing together buyers andsellers, and the term “marketing study” refers to the study of the needsand wants of buyers and sellers and how the buyers and sellers can cometogether.

The term “health study” refers to monitoring the health of an organismand studying the data regardless of the method of study.

The term “wellness” generally refers to a healthy balance of themind-body and spirit that results in an overall feeling of well-being,and/or the state of being healthy. The term “wellness study” refers tothe study of the quality of health and wellbeing. In some cases awellness study is performed by professionals in medicine or science. Inother cases, a clinical study is performed by amateurs, computerprograms, or individuals themselves, sometimes in the form of self help.

The term “dieting plan” refers to a method of planning and/or regulatingthe intake of food or nutrients into the body. The term “exercise plan”refers to a method of planning or regulating physical activity. In manycases, a diet/exercise plan are used together to improve or reducehealth. These plans can be operated by professionals, such asprofessional dieticians or physical trainers, or by amateurs. In somecases, these plans are regulated by computer programs or individualsthemselves, sometimes in the form of self help.

The term “health study” refers to studying health as in its raw form,without necessarily being concerned about interactions between healthand other factors.

The term “sickness and/or disease” refers generally to aspects of asickness, disease, or injury in an individual or group of individuals.

The term “environmental exposure” refers to any environmental occurrence(or energy) to which an individual or group of individuals is exposed.For example, exposure to solar energy, air pollution, temperature,nuclear radiation, humidity, water, etc. may all constituteenvironmental exposure. A variety of relevant environmental energies arelisted elsewhere herein.

In many cases, the above cases may overlap. As an example, a clinicalstudy or wellness study may explore or record the interaction betweenphysiological elements and environmental elements.

The term “aggregated” refers to information that is stored and/orgrouped. In some cases, these groupings can be based on personal ordemographical information, such as grouping based on ethnicity, sex,income, personal preferences or the like.

The terms “health and environmental network” and “health andenvironmental monitoring system” are used interchangeably herein. Theterms “monitoring system” and “network” may be used interchangeably, aswell.

The term “biofeedback” relates to measuring a subject's bodily processessuch as blood pressure, heart rate, skin temperature, galvanic skinresponse (sweating), muscle tension, etc., and conveying suchinformation to the subject in real-time in order to raise the subject'sawareness and conscious control of the related physiological activities.Herein, biofeedback is synonymous with personal physiologicalmonitoring, where biochemical processes and environmental occurrencesmay be integrated into information for one or more individuals. Forexample, monitoring hormone levels and air quality through theinnovative sensor network described herein for the purpose of tracking,predicting, and/or controlling ovulation is also considered biofeedback.

The term “profile” relates to a summary of noteworthy characteristicsand/or habits of an individual or group of individuals. Thesecharacteristics may be physiological (health-related), environmental,statistical, demographical, behavioral, and the like. Age, location,gender, sex, weight, ethnicity, and/or height may be included in aprofile. Additionally, a profile may reference the buying and/orspending habits of an individual or group. Profiles may be utilized inmaking predictions about an individual or group.

The term “support,” when used as a verb, means to assist and/or provideat least one method or outcome for something. For example, a method ofsupporting a therapy for something may refer to a method of assisting atherapeutic technique. In some cases, supporting a therapy may involveproviding an entirely new method having a therapeutic outcome. As a morespecific example, a noninvasive health and environmental monitorsystem/network may support a therapeutic drug study by noninvasivelymonitoring the real-time drug dosage in the body through multiwavelengthpulse oximetry, monitoring core body temperature through thermal sensingof the tympanic membrane, and monitoring environments which maypositively or negatively affect the quality of the drug therapy.

In the following figures, earpiece modules will be illustrated anddescribed for attachment to the ear of the human body. However, it is tobe understood that embodiments of the present invention are not limitedto those worn by humans. Moreover, monitoring apparatus according toembodiments of the present invention are not limited to earpiece modulesand/or devices configured to be attached to or near the ear. Monitoringapparatus according to embodiments of the present invention may be wornon various parts of the body or even worn inside the body.

Some embodiments of the present invention arise from a discovery thatthe ear is an ideal location on the human body for a wearable health andenvironmental monitor. The ear is a relatively immobile platform thatdoes not obstruct a person's movement or vision. Devices located alongthe ear can have access to the inner-ear canal and tympanic membrane(for measuring core body temperature), muscle tissue (for monitoringmuscle tension), the pinna and earlobe (for monitoring blood gaslevels), the region behind the ear (for measuring skin temperature andgalvanic skin response), and the internal carotid artery (for measuringcardiopulmonary functioning). The ear is also at or near the point ofexposure to: environmental breathable toxicants of interest (volatileorganic compounds, pollution, etc.); noise pollution experienced by theear; and lighting conditions for the eye. Located adjacent to the brain,the ear serves as an excellent location for mounting neurological andelectrical sensors for monitoring brain activity. Furthermore, as theear canal is naturally designed for transmitting acoustical energy, theear provides an optimal location for monitoring internal sounds, such asheartbeat, breathing rate, and mouth motion.

Bluetooth®-enabled and/or other personal communication earpiece modulesmay be configured to incorporate physiological and/or environmentalsensors, according to some embodiments of the present invention.Bluetooth® earpiece modules are typically lightweight, unobtrusivedevices that have become widely accepted socially. Moreover, Bluetooth®earpiece modules are cost effective, easy to use, and are often worn byusers for most of their waking hours while attending or waiting for cellphone calls. Bluetooth® earpiece modules configured according toembodiments of the present invention are advantageous because theyprovide a function for the user beyond health monitoring, such aspersonal communication and multimedia applications, thereby encouraginguser compliance. Exemplary physiological and environmental sensors thatmay be incorporated into a Bluetooth® or other type of earpiece moduleinclude, but are not limited to accelerometers, auscultatory sensors,pressure sensors, humidity sensors, color sensors, light intensitysensors, pulse oximetry sensors, pressure sensors, etc.

Wireless earpiece devices incorporating low-profile sensors and otherelectronics, according to embodiments of the present invention, offer aplatform for performing near-real-time personal health and environmentalmonitoring in wearable, socially acceptable devices. The capability tounobtrusively monitor an individual's physiology and/or environment,combined with improved user compliance, is expected to have significantimpact on future planned health and environmental exposure studies. Thisis especially true for those that seek to link environmental stressorswith personal stress level indicators. The large scale commercialavailability of such low-cost devices can enable cost-effective largescale studies. The combination of monitored data with user location viaGPS (Global Positioning System) and/or other location data can makeon-going geographic studies possible, including the tracking ofinfection over large geographic areas. The commercial application of theproposed platform encourages individual-driven health maintenance andpromotes a healthier lifestyle through proper caloric intake andexercise.

Embodiments of the present invention are not limited to devices thatcommunicate wirelessly. In some embodiments of the present invention,devices configured to monitor an individual's physiology and/orenvironment may be wired to a device that stores, processes, and/ortransmits data. In some embodiments, this information may be stored onthe earpiece module itself.

FIG. 1 is a block diagram illustrating a wearable monitoring device 10,according to some embodiments of the present invention. The illustratedwearable monitoring device 10 includes one or more of the following: atleast one physiological sensor 11, at least one environmental sensor 12(also referred to as an external energy sensor), at least one signalprocessor 13, at least one transmitter/receiver 14, at least one powersource 16, at least one communication & entertainment module 17, atleast one body attachment component 15, and at least one housing 18.Though the health and environmental sensor functionality can be obtainedwithout the communication and entertainment module 17, having thisadditional module may promote use of the wearable monitoring device 10by users. The illustrated wearable monitoring device 10 is intendedprimarily for human use; however, the wearable monitoring device 10 mayalso be configured for use with other animals. In one preferredembodiment, the wearable monitoring device 10 is an earpiece moduleattached to the ear.

A physiological sensor 11 can be any compact sensor for monitoring thephysiological functioning of the body, such as, but not limited to,sensors for monitoring: heart rate, pulse rate, breathing rate, bloodflow, heartbeat signatures, cardio-pulmonary health, organ health,metabolism, electrolyte type and concentration, physical activity,caloric intake, caloric metabolism, metabolomics, physical andpsychological stress levels and stress level indicators, physiologicaland psychological response to therapy, drug dosage and activity (drugdosimetry), physiological drug reactions, drug chemistry in the body,biochemistry, position & balance, body strain, neurological functioning,brain activity, brain waves, blood pressure, cranial pressure, hydrationlevel, auscultatory information, auscultatory signals associated withpregnancy, physiological response to infection, skin and core bodytemperature, eye muscle movement, blood volume, inhaled and exhaledbreath volume, physical exertion, exhaled breath physical and chemicalcomposition, the presence, identity, and concentration of viruses &bacteria, foreign matter in the body, internal toxins, heavy metals inthe body, anxiety, fertility, ovulation, sex hormones, psychologicalmood, sleep patterns, hunger & thirst, hormone type and concentration,cholesterol, lipids, blood panel, bone density, body fat density, muscledensity, organ and body weight, reflex response, sexual arousal, mentaland physical alertness, sleepiness, auscultatory information, responseto external stimuli, swallowing volume, swallowing rate, sickness, voicecharacteristics, tone, pitch, and volume of the voice, vital signs, headtilt, allergic reactions, inflammation response, auto-immune response,mutagenic response, DNA, proteins, protein levels in the blood, bodyhydration, water content of the blood, pheromones, internal body sounds,digestive system functioning, cellular regeneration response, healingresponse, stem cell regeneration response, and the like. Vital signs caninclude pulse rate, breathing rate, blood pressure, pulse signature,body temperature, hydration level, skin temperature, and the like. Aphysiological sensor may include an impedance plethysmograph formeasuring changes in volume within an organ or body (usually resultingfrom fluctuations in the amount of blood or air it contains). Forexample, the wearable monitoring device 10 may include an impedanceplethysmograph to monitor blood pressure in real-time.

An external energy sensor 12, serving primarily as an environmentalsensor, can be any compact sensor for monitoring the externalenvironment in the vicinity of the body, such as, but not limited to,sensors for monitoring: climate, humidity, temperature, pressure,barometric pressure, pollution, automobile exhaust, soot density,airborne particle density, airborne particle size, airborne particleshape, airborne particle identity, volatile organic chemicals (VOCs),hydrocarbons, polycyclic aromatic hydrocarbons (PAHs), carcinogens,toxins, electromagnetic energy (optical radiation, X-rays, gamma rays,microwave radiation, terahertz radiation, ultraviolet radiation,infrared radiation, radio waves, and the like), EMF energy, atomicenergy (alpha particles, beta-particles, gamma rays, and the like),gravity, light properties (such as intensity, frequency, flicker, andphase), ozone, carbon monoxide, greenhouse gases, CO2, nitrous oxide,sulfides, airborne pollution, foreign material in the air, biologicalparticles (viruses, bacteria, and toxins), signatures from chemicalweapons, wind, air turbulence, sound and acoustical energy (both humanaudible and inaudible), ultrasonic energy, noise pollution, humanvoices, animal sounds, diseases expelled from others, the exhaled breathand breath constituents of others, toxins from others, bacteria &viruses from others, pheromones from others, industrial andtransportation sounds, allergens, animal hair, pollen, exhaust fromengines, vapors & fumes, fuel, signatures for mineral deposits or oildeposits, snow, rain, thermal energy, hot surfaces, hot gases, solarenergy, hail, ice, vibrations, traffic, the number of people in avicinity of the user, the number of people encountered throughout theday, other earpiece module users in the vicinity of the earpiece moduleuser, coughing and sneezing sounds from people in the vicinity of theuser, loudness and pitch from those speaking in the vicinity of theuser, and the like.

In some embodiments, a physiological sensor 11 and/or an environmentalsensor 12 may be configured to identify a person, such as biometricidentification of a person, to whom the wearable monitoring device 10 isattached (or may be configured to identify other persons in the vicinityof the person wearing the monitoring device 10).

In some embodiments, a physiological sensor 11 and/or an environmentalsensor 12 may be configured to monitor physical aging rate of a personor subject. The signal processor 13 may be configured to processinformation from a physiological sensor and/or an environmental sensorto assess aging rate. Physiological sensors configured to assess agingrate may include pulse rate sensors, blood pressure sensors, activitysensors, and psychosocial stress sensors. Environmental sensorsconfigured to assess aging rate may include UV sensors and pollutionsensors.

In some embodiments, a physiological sensor 11 and/or an environmentalsensor 12 may be configured to be regenerated through a physical and/orchemical change. For example, it is anticipated that a wearablemonitoring device 10, or other device incorporating physiological and/orenvironmental sensors according to embodiments of the present invention,may be coupled to an apparatus that is configured to “recharge” orregenerate one or more environmental and/or physiological sensors via aphysical process or a chemical process, etc. For example, a rechargingmodule for recharging electric power to the wearable monitoring device10 may also user electrical energy to reverse a chemical or physicalchange in one of the sensors. One example of such a sensor would be asensor that requires the absorption or desorption of water vapor forresetting to baseline operation. Another example is a sensor that isreset (recharged) through oxidation or reduction in order to change thesurface properties for monitoring vapors, such as some metal oxidesensors.

Because the wearable monitoring device 10 is capable of measuring andtransmitting sensor information in real-time over a duration of time,the physiological and environmental sensors 11, 12 can be used to sensethe aforementioned parameters over time, enabling a time-dependentanalysis of the user's health and environment as well as enabling acomparison between the user's health and environment. Combined withproximity or location detection, this allows an analysis for pinpointingthe location where environmental stress and physical strain took place.

Proximity detection can be accomplished through GPS type devicesintegrated into the monitoring device 10 or a personal communicationdevice in communication with the monitoring device 10. Proximitydetection can also be accomplished through triangulation of wirelesssignals; if a cellular phone is used as the personal communicationdevice (such as 21 of FIG. 2), proximity can be identified throughexisting cellular infrastructure for identifying the time and locationof a phone call.

The signal processor 13 provides a means of converting the digital oranalog signals from the sensors 11, 12 into data that can be transmittedwirelessly by the transmitter 14. The signal processor 13 may becomposed of, for example, signal conditioners, amplifiers, filters,digital-to-analog and analog-to-digital converters, digital encoders,modulators, mixers, multiplexers, transistors, various switches,microprocessors, or the like. For personal communication, the signalprocessor 13 processes signals received by the receiver 14 into signalsthat can be heard or viewed by the user. The received signals may alsocontain protocol information for linking various telemetric modulestogether, and this protocol information can also be processed by thesignal processor 13.

The signal processor 13 may utilize one or morecompression/decompression algorithms (CODECS) used in digital media forprocessing data. The transmitter 14 can be comprised of a variety ofcompact electromagnetic transmitters. A standard compact antenna is usedin the standard Bluetooth® headset protocol, but any kind ofelectromagnetic antenna suitable for transmitting at human-safeelectromagnetic frequencies may be utilized. The receiver 14 can also bean antenna. In some embodiments, the receiving antenna and thetransmitting antenna are physically the same. The receiver/transmitter14 can be, for example, a non-line-of-sight (NLOS) optical scattertransmission system. These systems typically use short-wave (blue or UV)optical radiation or “solar blind” (deep-UV) radiation in order topromote optical scatter, but IR wavelengths can also suffice.

Additionally, a sonic or ultrasonic transmitter can be used as thereceiver/transmitter 14 of the wearable monitoring device 10, butpreferably using sounds that are higher or lower than the human hearingrange. A variety of sonic and ultrasonic receivers and transmitters areavailable in the marketplace and may be utilized in accordance withembodiments of the present invention. If a telecommunication device 21(FIG. 2) receiving wireless data signal 19 from the wearable monitoringdevice 10 is in close proximity to the wearable monitoring device 10,and the wearable module is an earpiece module, a variety of transmissionschemes can be used. For communicating audible conversationalinformation directly to the earpiece user, encoded telemetricconversational data received by the receiver 14 can be decoded by thesignal processing module 13 to generate an electrical signal that can beconverted into audible sound by the communication module 17.

In some embodiments, the transmitter/receiver 14 is configured totransmit signals from the signal processor to the remote terminalfollowing a predetermined time interval. For example, the transmittermay delay transmission until a certain amount of detection time haselapsed, until a certain amount of processing time has elapsed, etc. Insome cases, the transmitter/receiver 14 is configured to transmitsignals to the remote terminal dependent on information sensed by thesensors 11, 12. For example, if an unstable pulse rate is sensed, awarning message may be sent to a remote terminal to communicate a needfor help at a particular location.

The power source can be any portable power source 16 capable of fittinginside the housing 18. According to some embodiments, the power source16 is a portable rechargeable lithium-polymer or zinc-air battery.Additionally, portable energy-harvesting power sources can be integratedinto the wearable monitoring device 10 and can serve as a primary orsecondary power source. For example, a solar cell module can beintegrated into the wearable monitoring device 10 for collecting andstoring solar energy. Additionally, piezoelectric devices ormicroelectromechanical systems (MEMS) can be used to collect and storeenergy from body movements, electromagnetic energy, and other forms ofenergy in the environment or from the user himself. A thermoelectric orthermovoltaic device can be used to supply some degree of power fromthermal energy or temperature gradients. In some embodiments, a crankingor winding mechanism can be used to store mechanical energy forelectrical conversion or to convert mechanical energy into electricalenergy that can be used immediately or stored for later.

The various components described above are configured to fit within thewearable monitoring device housing 18 and/or be attached thereto. In thecase where the wearable monitoring device 10 is an earpiece module, thehousing 18 may be formed from any safe and comfortable solid material,such as metal, rubber, wood, polymers, ceramic, organic materials, orvarious forms of plastic. The body attachment component 15 is attachedto the housing 18 and is designed to fit around or near the ear. Forexample, the standard Bluetooth® headset includes an earpiece attachmentthat is connected to the headset housing via a double-jointed socket, toprovide comfort and positioning flexibility for the user. In someembodiments, the body attachment component 15 can be part of the housing18, such that the entire earpiece module is one largely inflexible,rigid unit. In such case, a counterweight may be incorporated into thewearable monitoring device 10 to balance the weight of the earpieceelectronics and power source. In some embodiments, the body attachmentcomponent 15 can contain physiological and environmental sensors, andthe body attachment component 15 may be detachable. In some embodiments,more than one earpiece attachment 15 can be attached to the housing 18.

The communication and entertainment module 17 (also interchangeablyreferred to as a “communication module”) is used for, but not limitedto: processing or generating an audible sound from information receivedvia the receiver 14 (from a cell phone, computer, network, database, orthe like) and/or processing or generating an electrical signal from anaudible sound from the user such that the electrical signal can betransmitted telemetrically via the transmitter 14. For example, instandard Bluetooth® protocol, communication electronics are used toconvert an audible conversation into an electrical signal for telemetricconversation; communication electronics are also used to convert adigitized telemetric conversation into an audible conversation for theearpiece user. Additionally, the communication and entertainment module17 can be used to store, process, or play analog or digital informationfrom music, radio shows, videos, or other audible entertainment and tocommunicate this information to an earpiece user. In many cases, thisinformation includes information received by the receiver 14. In manycases, the analog or digital information is not stored in thecommunication and entertainment module 17 but, rather, is stored in aportable telecommunication device 21 (FIG. 2). In such case, thecommunication and entertainment module 17 is used for converting theanalog or digital information into audible sound for the earpiece user.The communication and entertainment module 17 may contain at least onemicrophone, speaker, signal processor (similar to 13), and digitalmemory. In some embodiments, the communication and entertainment module17 may apply at least one CODEC for encoding or decoding information.The communication and entertainment module may utilize non-audible formsof communication with the user, such as visual, physical, or mental(i.e., brainwaves or neural stimulation) communication with the user.

In some embodiments, an audible communicator is provided that isconfigured to communicate therapeutic sounds (e.g., music therapy, etc.)to a person in response to physiological or psychosocial stress. Theaudible communicator may be embodied in the communication andentertainment module 17 or may be a separate speaker. In someembodiments, light therapy may be provided to a person in response tophysiological or psychosocial stress. In some embodiments, thecommunication and entertainment module 17 may be configured tocommunicate a treatment, therapy, and/or plan of action to the personupon detection of physiological and/or environmental concerns. Forexample, if it is detected that the person is being exposed to unhealthydoses of UV radiation, the communication and entertainment module 17 mayaudibly instruct the person to move away from the person's currentlocation (e.g., move indoors, etc.). Mechanical vibrational therapy andelectrical stimulation therapy are also examples of automated therapiesthat may be invoked by programs inside the monitoring device 10 inresponse to sensor readings from health 11 and/or environmental 12sensors.

Like the other components of the wearable monitoring device 10 shown inFIG. 1, the components of the communication and entertainment module 17are not necessarily located in the same physical vicinity. Themicrophone and speaker of the communication module 17, for example, maybe located closer to the mouth and ear respectively. Furthermore, thesignal processor 13 can be composed of several components locatedthroughout the earpiece module. It should be understood that the word“module” does not necessarily imply a unified physical location. Rather,“module” is used to imply a unified function.

Bluetooth® devices conventionally contain a communication module, suchas communication module 17, for converting digital or analog informationinto audible sounds for the user. However, when combined with the healthand environmental monitoring properties of a wearable monitoring device10 according to embodiments of the present invention, the communicationand entertainment module 17 can provide functionality. For the wearablemonitoring device 10 can serve as a biofeedback device. As anon-limiting example, if a user is in a polluted environment, such asair filled with VOCs, the communication module 17 may notify the user tomove to a new environment. As another example, if one or more of thephysiological and environmental sensors 11, 12 of the wearablemonitoring device 10 pick up a high particulate density in theenvironment, with an elevation in core body temperature, and a change invoice pitch occurring simultaneously (or near-simultaneously) within acommon timeframe, the communication module 17 may alert the user thathe/she may be having an allergic response. As a further example, theuser can use the communication and entertainment module 17 to executebiofeedback for willfully controlling blood pressure, breathing rate,body temperature, pulse rate, and the like. The communication module 17may utilize audible or visible alerts if the user is meeting theirphysiological targets or exceeding safe physiological limits. Alerting auser by physical or electrical force, such as the sense of touch ortingling from an electric pulse or vibration, can also be utilized.Thus, although communication by audible means is often utilized, thecommunication module 17 can alert, signify, or communicate with the userthrough sound, light, electrical actuation, and physical actuation.

As a second example of this biofeedback method, basic vital signscollected by the physiological sensors 11 and processed by the signalprocessor 13 can be presented to the monitoring device user audibly,through the communication and entertainment module 17. For example, theuser may be able to listen to his/her breathing rate, pulse rate, andthe like. Additionally, an entertaining or aggravating sound or song canbe used to alert the user to favorable or unfavorable personal healthand environmental factors occurring in real-time. This technique may beapplied towards education, such as positive or negative feedback foreducational games, learning games, or games of deception (e.g., poker,etc.). FIG. 9 illustrates the display of physiological information andenvironmental information collected by a monitoring device 10 via auser's cell phone, according to some embodiments of the presentinvention.

In some embodiments, the wearable monitoring device 10 may be configuredto deliver and/or monitor drugs, as in a dosimeter. For example, atransdermal drug delivery system may be provided that is controlled bymonitoring device 10 electronics. Physiological sensors 11 can monitorthe drug dosage and the physiological effects of the drug in real-time.

A health and environmental monitoring system 20 according to embodimentsof the present invention that may incorporate wearable monitoringdevices 10 of FIG. 1 is illustrated in FIG. 2. Other types of wearablemonitoring devices may also be utilized in the health and environmentalmonitoring system 20. The wearable monitoring device 10 is utilized as aspecific monitoring device 21 of the monitoring system 20, though othermodules located at various other parts of the body can be used inconjunction with, or in place of, the wearable monitoring device 10. Theterms “wearable monitoring device” and “sensor module” are usedinterchangeably herein in accordance with various embodiments of thepresent invention. The health and environmental monitoring system 20 iscomposed of at least one sensor module 21 (e.g., wearable monitoringdevice 10) at least one portable telecommunication module 22, at leastone transmission system 23, at least one user interface 24, at least onepersonal database 25, and at least one anonymous database 26.

The sensor module 21 can be composed of a primary module alone or aprimary module and at least one secondary module. The primary andsecondary modules can be located at any location of the body, but inmany cases it is preferable to be located in a region at or near theear, and preferably the wearable monitoring device 10 serves as theprimary module. In many cases, the secondary modules are not necessary.But in some cases, secondary modules may be located, for example, behindthe ear (near the lymph nodes), at or near the earlobes (such as one ormore earrings or ear clips), at the front of the ear (near the carotidartery), at the temples, along the neck, or other locations near theear. In some cases the secondary modules, as with the primary module,can be located inside the body. These wearable secondary modules can beconnected with either a “hard” connection to the primary module (such asan electric cable) or a “soft” connection to the primary module (such asa wireless connection). In Bluetooth® protocol, each secondary modulecan be simultaneously in direct wireless communication with the primarymodule. Primary modules and secondary modules in the same location canpromote quick-donning, ease-of-use, and comfortability for the end user.Users may not be prone to accept multiple modules at multiple locationsof the body.

The wearable sensor module 21 communicates wirelessly with the portabletelecommunication device 22, preferably in an open architectureconfiguration, such as Bluetooth® or ZigBee. The telecommunicationdevice 22 can be any portable device, such as a cell phone (whichincludes a “smartphone”), PDA, laptop computer, Blackberry, anotherearpiece, or other portable, telemetric device. The portabletelecommunication device 22 and the wearable sensor module 21 cantelemetrically communicate both to and from each other. Though the mainpurpose of the portable telecommunication device is to transmit thelocal wireless signal from the sensor module 21 over longer distancesunattainable by the transmitter 14 of the sensor module 21, thetelecommunication device 22 can also serve as a method of personalcommunication and entertainment for the earpiece user.

In some embodiments, the telecommunication device 22 transmits data inonly one direction or particular directions. For example, in oneembodiment, the portable telecommunication device 22 can receivetelemetric information from the sensor module 21 but cannot send outsignals to a transmission system 23. The portable telecommunicationdevice 22 may also contain an end-user graphical interface, such as auser interface 24 in the monitoring system 20, such that data from thewearable sensor module 21 can be stored, analyzed, summarized, anddisplayed on the portable telecommunication device 22. For example,charts relating health and environment, as well as real-time biofeedbackand the like, can be displayed on a cell phone, media player, PDA,laptop, or other device. The telecommunication device 22 may alsocontain physiological and environmental sensors itself, such as sensorsfor blood pressure, pulse rate, air quality, pulse-oximetry, and thelike. Additionally, the telecommunication device 22 can communicate withthe wearable sensor module 21 to transfer commands, activate ordeactivate sensors, communicate with the user, and the like.

The portable telecommunication device 22 sends/receives wirelessinformation directly to/from a transmission system 23 for transmissionto a database (such as personal database 25 and/or anonymous database26) for storage, analysis, and retrieval of data. The style oftransmission system may depend largely on the location of the database.For example, if the database is located in a local computer, thewireless information from the telecommunication device 22 can be sentdirectly to the local computer. This computer may be connected with theInternet, allowing access to the database from the web. However, thedatabase is more typically located far away from the user andtelecommunication module. In this case, the wireless signal from thetelecommunication device 22 can be sent to a reception tower and routedthrough a base station. This information can then be sent to a databasethrough the Internet. A variety of other transmission protocols can beapplied for connection between the telecommunication device 22 and thedatabases 25 and 26.

The personal and anonymous databases 25, 26 represent databases that mayor may not be located on the same computer. A difference between thesetwo databases is not the physical location of the database but ratherthe type of information available on each database. For example, theanonymous database 26, containing aggregated health and environmentaldata from multiple indistinct monitoring device users, can be public andaccessible through the Internet by various users. In contrast, thepersonal database 25 contains health and environmental data that ispersonalized for each monitoring device user, including personalizedinformation such as name, birth date, address, and the like. Users canlog-in to their personalized information in the personal database 25through an interactive user interface 24 and compare this informationwith information from multiple users in the anonymous database 26 via agraphical user interface, etc. In some cases, the wearable sensor module21 or portable telecommunication device 22 may additionally communicateinformation not directly related to health and environment, such asphysical location, personal information, proximity to various locationsor properties, etc., to either database. In some cases, this additionalinformation may be sensed by the wearable sensor module 21 and/or bysensors and/or protocols integrated into portable communication device22.

The user interface 24 can be a computer monitor, a cell phone monitor, aPDA monitor, a television, a projection monitor, a visual monitor on thewearable sensor module 21, or any method of visual display. (Audiblemethods and audio-visual methods can also be used for the user interface24, as well as mechanical methods such as automated brail displays forthe blind.) For example, the user may log-in to their personal database25 through a computer user interface 24 and compare real-time personalhealth and environmental exposure data with that of other users on themonitoring system 20. In some cases, the data from other users may beanonymous statistics. In some cases, one or more users may haveagreements to view the data of one or more other users, and in othercases, users may agree to share mutual personalized data through theInternet.

A specific embodiment of a graphical user interface 30 is presented inFIG. 3. FIG. 3 shows an example of how a computer monitor may appear toa user logging-in to their personal database 25 and comparing their ownpersonal data with that of anonymous users in the same monitoring system20. In this case, data from anonymous users is averaged into certaindemographics; the choice of the demographics to be displayed can beselected by the user accessing the personalized database. In thegraphical user interface 30 of FIG. 3, the user's personalized data,signified by a star, is compared with statistics from other users in ananonymous database 26. This allows the user to compare his/her healthand environment with that of others in selected demographics. FIG. 10illustrates an exemplary user interface that a user can access tocompare himself/herself to others, according to some embodiments of thepresent invention.

Monitoring system 20 serves not only as a source of useful informationfrom a medical standpoint, but also as a form of entertainment forcurious users. It is important to note that health and environmentalinformation from multiple subjects may be updated regularly. In somecases, the regular updates are real-time (or “near-real-time”) updates.Thus, information is always new and fresh with respect to daily changesin a group of subjects, and the plots of FIG. 3 are dynamic, changing intime with changing user health and/or environmental information.

The monitoring system 20 can be used in medicine for a variety ofimportant functions. As one example, a doctor can monitor the health ofpatients through each patient's personalized database 25. If thewearable sensor module 21 contains a dosimeter, the doctor can evenmonitor the efficacy of prescribed medications, and the physiologicalresponse to medications, over time. This dosimetry approach is directlyapplicable to clinical studies of various treatments. For example,during a clinical trial, the wearable sensor module 21 can collectenvironmental data, drug dosimetry data, and physiological data from theearpiece user such that researchers can understand the epidemiologybetween drugs, genes, physiology, environment, and personal health.

Because of the high compliance of the wearable monitoring device 10,primarily due to the dual-modality as a health/environmental monitor anda personal communication/entertainment device, users are prone to wearthis device throughout clinical trials, providing more valuableinformation for drug discovery and the pharmaceuticals market.

As a further example, the health and environmental monitoring system 20can be used by dieticians to track the caloric intake, health, andphysical activity of dieters. Similarly, the monitoring system 20 can beused by athletic trainers to monitor the diet, physical activity,health, and environment of athletes. In many cases professionals are notnecessary, and the user can monitor his/her own diet, activity, athleticperformance, etc. through the monitoring system without professionals,parents, guardians, or friends monitoring their personal statistics.

In a specific example of the monitoring system 20, a test subject in aclinical trial for a new treatment, such as a new drug, physicaltherapy, medical device, or the like, is wearing at least one monitor21. The subject's health and environment are monitored in real-time, andthis data is stored on the wearable sensor module 21, the portabletelecommunication device 22, the personal database 25, and/or theanonymous database 26. By accessing the stored data, researchersmanaging the clinical trial can then compare the statistics frommultiple users to make correlations between user environment, health,and the effectiveness of treatment.

According to some embodiments of the present invention, a method ofmonitoring one or more subjects includes collecting physiological and/orenvironmental information from a monitoring device associated with eachrespective subject, storing the collected physiological and/orenvironmental information at a remote storage device, and comparing thestored physiological and/or environmental information with benchmarkphysiological and/or environmental information to identify at least onebehavioral response of the one or more subjects. As described above,each monitoring device includes at least one physiological sensor and/orenvironmental sensor. Exemplary behavioral responses include behavioralresponses to a product and/or service, behavioral responses to productand/or service marketing, behavioral responses to medical treatment, andbehavioral responses to a drug.

It should be noted that algorithms for processing personal health andenvironmental data, diagnosing medical conditions, assessing healthstates, and the like do not need to be limited to the illustratedmonitoring system 20. Various algorithms can also be integrated into thewearable sensor module 21 or telecommunication device 22 according toembodiments of the present invention. A data storage component in atleast one of these units allows processed signal data to be stored,analyzed, and manipulated to provide new knowledge to the user. Thisstorage component can be any solid-state storage device, such as flashmemory, random-access memory (RAM), magnetic storage, or the like. Forexample, the wearable sensor module 21 can be programmed to monitorcertain habits, such as nail-biting. In this non-limiting example, thephysiological sensors 11 may monitor internal sounds, and an algorithmcan be implemented to monitor signatures of nail-biting sounds inreal-time. If the habit is identified by the algorithm, thecommunication module 17 may instantly warn the user that the habit isoccurring. Alternatively, the algorithm may count the number of times aday the habit occurred, monitor physiological and psychological stressindicators during each occurrence, log each time when the habitoccurred, and store environmental data associated with the habit. Thisstored data can be accessed at a later time, allowing the user todetermine what environmental factors cause the physiological orpsychological stress associated with nail-biting. As this example shows,these algorithms can take advantage of both physiological sensor dataand environmental sensor data.

According to some embodiments of the present invention, a method ofsupporting interpersonal relationships includes collecting physiologicaland/or environmental information from a monitoring device associatedwith a person when the person is in the presence of another person,determining a stress level of the person using the collectedphysiological and/or environmental information, and displaying thestress level to the person (or to others). As described above, themonitoring device 10 includes at least one physiological sensor and/orenvironmental sensor, wherein each physiological sensor is configured todetect and/or measure physiological information from the person, andwherein each environmental sensor is configured to detect and/or measureenvironmental conditions in a vicinity of the person. The collectedphysiological and/or environmental information includes indicatorsassociated with stress experienced by the person;

According to some embodiments of the present invention, physiologicaland/or environmental information collected from the person over a periodof time can be stored and subsequently analyzed. For example, a stresslevel of the person over a period of time can be determined using thestored information, and can be displayed to the person (or to otherpersons). FIG. 11 illustrates the display of stress over time for auser, according to some embodiments of the present invention.

According to some embodiments of the present invention, physiologicaland/or environmental information collected from a person can be analyzedto identify a source of stress to the person, and one or more solutionsfor reducing stress can be recommended to the first person, for examplevia the monitoring device 10 (or in other ways).

A data storage component may include various algorithms, withoutlimitation. In some embodiments, at least one algorithm is configured tofocus processing resources on the extraction of physiological and/orenvironmental information from the various environmental and/orphysiological sensors. Algorithms may be modified and/or uploadedwirelessly via a transmitter (e.g., receiver/transmitter 14 of thewearable monitoring device 10)

The biofeedback functionality of the telemetric wearable monitoringdevice 10 can be applied towards various gaming applications. Forexample, one or more subjects can connect their wearable monitoringdevices 10 to one or more gaming devices wirelessly through the openarchitecture network provided by Bluetooth®, ZigBee, or other suchnetworks. This allows personal health and environmental information tobe transferred wirelessly between the wearable monitoring device 10 anda gaming device. As subjects play a game, various personal health andenvironmental feedback can be an active component of the game. In anon-limiting embodiment, two users playing a dancing game, such as DanceDance Revolution, can monitor their vital signs while competing in adancing competition. In some cases, users having healthier vital signs,showing improved athletic performance, will get extra points (“VitalPoints”). In another specific example, this personal health andenvironmental information can be sent telemetrically to a gaming deviceto make entertaining predictions about one or more users. Namely, thegaming device may predict someone's life expectancy, love-life, futureoccupation, capacity for wealth, and the like. These predictions can betrue predictions, purely entertaining predictions, or a mixture of both.Sensors measuring external stressors (such as outside noise, lightingconditions, ozone levels, etc.) and sensors measuring internal stresses(such as muscle tension, breathing rate, pulse rate, etc.) integratedinto the wearable monitoring device 10 can be used to facilitatepredictions by the gaming device. For example, the information from thesensors can be recorded from one or more subjects wearing a sensormodule 21 during a series of questions or tasks, and the information canbe sent telemetrically to a gaming device. An algorithm processed in thegaming device can then generate an entertaining assessment from theinformation. This game can be in the form of a video game, with agraphical user interface 24, or it can be a game “in person” through anentertainer. Other games can involve competitions between multiplewearable monitor users for health-related purposes, such as onlinedieting competitions, fitness competitions, activity competitions, orthe like. Combining the telemetric wearable monitoring device 10 withgaming, according to embodiments of the present invention, providesseamless interaction between health and environmental monitoring and thegame, through a comfortable telemetric module. Other sensor modules 21located at various parts of the body can also be used.

An additional non-limiting embodiment of the biofeedback functionalityof a wearable sensor module 21, according to some embodiments of thepresent invention, include monitoring psychological and physiologicalstress (such as monitoring stress indicators) during a poker game. Thesestress indicators can be breathing rate, muscle tension, neurologicalactivity, brain wave intensity and activity, core body temperature,pulse rate, blood pressure, galvanometric response, and the like. Usersmay, for example, use the wearable sensor module 21 to record or displaytheir psychological and physiological stress during a poker game inreal-time. This information can be stored or displayed on a portabletelecommunication device 22 or sent wirelessly to other parts of themonitoring system 20. The user can use this biofeedback to adjust theirpsychological and physiological stress (or stress indicators) throughforce of will. This biofeedback process allows earpiece users toself-train themselves to project a certain “poker face,” such as a stoiccold look, a calm cool look, or another preferred look. Additionally,external stressors, such as light intensity and color, external sounds,and ambient temperature, can be sensed, digitized, and transmitted bythe wearable monitoring device 10 to a telecommunication device (forstorage), providing the user with important information about how theexternal environment may be affecting their stress response and, hence,poker game. In some games, the stress indicators may be displayed foroutside viewers (who are not part of the poker game) as a form ofentertainment when watching a group of poker players (each havingearpiece modules 21) in a casino, television, or through the Internet.

Physiological and/or environmental information collected from sensors11, 12 in a wearable module 21 (10) may be corrupted by the motionartifacts of a subject. As a specific example, when measuring pulse ratein a subject via photoplethysmography while the subject is walking,optical scatter associated with footstep-related skin vibrations may bemisinterpreted as coming from a pulse. This problem can be especiallydifficult where footstep rates are on the order of normal human pulserates. By measuring body motion in real-time via one or moreaccelerometers inside the wearable monitor 21 (10), sampled pulse ratedata can be processed to subtract, reduce, or eliminate signalsassociated with footsteps. In some cases, the processor 13 may simplysend a command to ignore the sampling and/or logging of pulse rate whenbody motion is detected. In this way, average pulse rate estimate is notconvoluted with footstep information. In other cases, the processor 13may correct for body motion in real time through dynamic feedback fromthe aforementioned accelerometer. A variety of other body motionsensors, such as acoustic sensors for monitoring footstep sounds andMEMS motion sensors, can also be used to monitor footsteps and correctphysiological and/or environmental data for motion artifacts. Animportant innovation afforded by the databases 25, 26 is that motionartifacts in the data can be corrected by applying algorithms forreviewing the physiological and/or environmental history of eachsubject, identifying corruptions associated with motion artifacts, andextracting physiological and/or environmental information from corrupteddata.

Information collected from one or more subjects wearing a sensor module21 in the monitoring system 20, can be integrated into a game for anovel gaming experience. For example, information collected from healthand environmental monitors worn by a user throughout the day can be usedto build a gaming character based on that user. With a group of subjectswearing such monitors throughout the day, a novel gaming environmentbased on a plurality of real life characters can be generated. Becauseinformation from each subject is updated on a regular basis with themonitoring system 20, information about characters can always be freshand dynamic, changing as the health and environment of each subjectchanges. Information from a group of subjects sharing a common qualitycan be summarized into a single character or group of characters basedon the aggregated dynamic changes in the health and/or environmentwithin the representative group.

The biofeedback approach is also directly relevant to personal educationas a learning tool. For example, monitoring the physiological andpsychological response to learning can be used to help users understandif they are learning efficiently. For example, in the course of reading,the wearable sensor module 21 can monitor alertness throughgalvanometric, brainwave, or vital sign monitoring. The user can thenuse this information to understand what reading methods or materials arestimulating and which are not stimulating to the earpiece user.

Biofeedback methods, according to embodiments of the present inventioncan be used as self-training tools for improving performance in publicspeaking, athletic activity, teaching, and other personal andjob-related activities.

A health and environmental monitoring system 20, according to someembodiments of the present invention, enables a variety of additionalbusiness methods for exploiting user information collected by the system20. For example, users can be charged a fee for downloading or viewingdata from the personal and/or anonymous databases 25, 26. Alternatively,users may be allowed free access but may be required to register online,providing personal information with no restrictions on use, for theright to view information from the databases. In turn, this personalinformation can be traded or sold by the database owner(s). Thisinformation can provide valuable marketing information for variouscompanies and government interests. The health and environmental datafrom the databases 25, 26 can be of great value itself, and this datacan be traded or sold to others, such as marketing groups,manufacturers, service providers, government organizations, and thelike. A web page or web pages associated with a personal and anonymousdatabase 25, 26 may be subject to targeted advertising. For example, ifa user shows a pattern of high blood pressure on a personal database 25,a company may target blood pressure treatment advertisements on the userinterface 24 (i.e., web page) while the user is logged-in to thepersonal database through the user interface 24. For example, becausevarious health and environmental statistics of subjects in themonitoring system 20 will be available on the database, this informationcan be used to provide a targeted advertising platform for variousmanufacturers. In this case, a database manager can sell information toothers for targeted advertising linked to a user's personal statistics.In some cases, a database owner does not need to sell the statistics inorder to sell the targeted advertising medium. As a specific example, acompany can provide a database owner with statistics of interest fortargeted advertising. For example, the company may request advertising aweight-loss drug to anonymous users having a poor diet, high caloricintake, and/or increasing weight. A database manager can then charge thecompany a fee for distributing these advertisements to the targetedusers as they are logged-in to the database website(s). In this way, theusers remain anonymous to the company. Because targeted advertisementscan be such a lucrative market, income from these sources may eliminatethe need for charging users a fee for logging-in to the databases 25,26.

According to some embodiments of the present invention, a method ofdelivering targeted advertising to a person includes collectingphysiological and/or environmental information from the person,selecting an advertisement for delivery to the person based upon thecollected physiological and/or environmental information, and deliveringthe selected advertisement to the person. Collecting informationincludes receiving physiological and/or environmental information from amonitoring device associated with the person. Selecting an advertisementincludes analyzing the received physiological and/or environmentalinformation to identify a physiological condition of the person and/orenvironmental condition in a vicinity of the person, and selecting anadvertisement for a product or service related to an identifiedphysiological and/or environmental condition. Delivery of a selectedadvertisement can be via any of many different channels including, butnot limited to, email, postal mail, television, radio, newspaper,magazine, the internet, and outdoor advertising.

There are many ways to profit from a health and environmental monitoringsystem 20, according to embodiments of the present invention. Forexample, information from subjects can be used to target onlineadvertisements or links to a particular subject or group of subjects,where these advertisements or links are tailored to informationcollected from each subject in the monitoring system 20 through sensormodules 21. In some cases, a targeted online link, tailored to a subjector group of subjects, may not necessarily constitute an advertisementbut rather a targeted link corresponding to a targeted good or service.Additionally, advertisements need not be limited to onlineadvertisements. The collected information can be used for targetedmailings, television commercials, newspaper/magazine ads, billboards,and the like.

A wearable sensor module 21 and health and environmental monitoringsystem 20 can enable a variety of research techniques. For example, aplurality of monitoring devices 10 worn by users can be used inmarketing research to study the physiological and psychological responseof test subjects to various marketing techniques. This technique solvesa major problem in marketing research: deciphering objective responsesin the midst of human subjectivity. This is because the physiologicaland psychological response of the earpiece user largely representsobjective, unfiltered information. For example, users that areentertained by a pilot TV program would have difficulty hiding innatevital signs in response to the program. The data generated by thewearable sensor module 21 during market research can be transmittedthrough any component of the telemetric monitoring system 20 and used bymarketing researchers to improve a product, service, or method.

Another method provided by the monitoring system 20 is to charge usersof the monitoring system for usage and service (such as compilationservice). For example, a clinical trial company may pay a fee foraccessing the databases 25, 26 of their test subjects during medicalresearch. In this case, these companies may buy modules 21 and pay forthe service, or the modules 21 may be provided free to these companies,as the database service fee can provide a suitable income itself.Similarly, doctors may pay for this service to monitor patients; firefighters and first responders may pay for this service to monitorpersonnel in hazardous environments; and athletic trainers may pay forthis service to monitor athletes. Also, users can pay for the databaseservice directly themselves. Because these databases 25, 26 are dynamic,updated regularly via a wearable sensor module 21 of each user, withdata changing with time for individual users and users en mass, thesedatabases can maintain a long-term value. In other words, there mayalways be new information on the databases 25, 26.

Another embodiment of the present invention involves methods ofcombining information from various sensors 11, 12 into a meaningfulreal-time personal health and environmental exposure assessment in arecording device. The meaningful assessment is generated by algorithmsthat can be executed in the sensor module 21, in the portabletelecommunication device 22, or through various other electronic devicesand media within the monitoring system 20. In one embodiment, raw orpreprocessed data from the sensor module 21 is transmitted wirelessly tothe telecommunication device 22, and this device executes variousalgorithms to convert the raw sensor data (from one or more sensors)into a meaningful assessment for the user. For example, a blood pressureassessment may be processed from stored raw data on personal database 25and/or anonymous database 26 collected from pulse rate sensors, pulsevolume sensors, and blood flow sensors in the wearable sensor module 21.In another embodiment these algorithms are executed within the sensormodule 21 itself, without the need for processing in thetelecommunication device 22, through a processor 13 inside the module 21(10). The output from these algorithms can be viewed as charts, graphs,figures, photos, or other formats for the user to view and analyze.Preferably, these formats display various health factors over time withrespect to a particular environment, with health factor intensity on thedependent axis and time or environmental factor intensity on theindependent axis. However, virtually any relationship between thephysiological data and environmental data can be processed by analgorithm, and these relationships can be quantitative, qualitative, ora combination of both.

One innovation involves applying the wearable sensor module 21 towards aphysical or mental health assessment method. An algorithm may combinedata from health and environmental sensors 11, 12 towards generating apersonal overall health assessment for the user, conditional to aparticular environment. For example breathing rate, pulse rate, and corebody temperature can be compared with ozone density in the air forgenerating an ozone-dependent personal health assessment. In anotherspecific example of this innovation, information from the sensors 11, 12can be used to monitor overall “mood” of a user in a particularenvironment. More particularly, algorithmic processing and analyzing ofdata from sensors for core body temperature, heart rate, physicalactivity, and lighting condition can provide a personal assessment ofoverall mood conditional on external lighting conditions.

Mood sensing in the wireless sensing monitoring system 20 can beimplemented in a variety of novel ways. A case example is that of a girlwearing a sensor module 21, in the form factor of a Bluetooth® headset(earpiece), embedded with sensors and a processor for monitoring overallmood. As the girl's mood changes, the headset monitor 21 senses,processes, and transmits mood to portable communication device, such asa cell phone. The cell phone may then send a text message (or other typeof communication), manually or automatically via a stored program, to aboyfriend, notifying the boyfriend of a change in mood. This allows theboyfriend to respond more rapidly and efficiently to mood changes.Similarly, aggregated mood data from a variety of users wearing similaror identical monitors can be used to track mood in a population studyfor one or more groups of people.

An application of the health and environmental monitoring system 20 issupporting interpersonal relationships between individuals and/or groupsof individuals. For example, subjects wearing a monitoring device 21(10) can track stress rates when interacting with certain othersubjects. As a more specific example, a subject wearing a monitoringdevice 21, containing physiological and/or environmental sensors fortracking indicators associated with stress, can track their stress levelin the presence of their spouse, children, coworkers, etc. through theuser interface 24. As the subject interacts throughout the day, thewearable monitoring device 21 may communicate stress updates through thewireless monitoring system 20 for storage in databases 25 and/or 26.Through the view screen of a computer, the user can then track a historyof stress levels while interacting with certain individuals. Thecorrelation between stress level and particular individuals may bedecided based on the time of day or a time mark selected by the subjectwearing the monitor 21. In some cases, the monitor 21 may be programmedto recognize other individuals audibly and/or visually or through acertain environment common to other individuals through sensors 11, 12integrated into the monitor 21 (10), and this correlation may then betransmitted wirelessly to the databases 25 and/or 26 for tracking stresswith respect to a particular interpersonal relationship. The stressrecord stored in the databases can then be used by professionals or theindividuals themselves to uncover the sources of stress and recommendsolutions or therapies for reducing stress in an interpersonalrelationship. In some cases, the correlation with the stress of asubject and the subject's environment may be all that is of interest, inwhich case detecting other individuals is not necessary.

Applying sensor information from the sensor monitoring system 20 towardspredictions for individual subjects and groups of subjects is anotherembodiment of the present invention. Health and/or environmentalinformation from individuals in the monitoring system can be used topredict an individual's behavior, health, the onset of a healthcondition, etc. Collectively, information from multiple subjects in themonitoring system 20 can be used to predict the outbreak of a disease,environmental situation, traffic conditions, mass behavior (such asmarket behavior), and the like. As a specific examples, sensors formonitoring physiological and/or environmental parameters associated withinfluenza may monitor changes in core body temperature, voice pitchchanges, pulse rate changes, etc. in a subject, or group of subjects,wearing a module 21, and this information may be processed into aprediction of the onset of influenza for the subject or group ofsubjects. Indeed, the onset of a mass outbreak can be predicted. Avariety of predictive techniques can be used to predict behavior basedon user information from the monitoring system 20. Predictions can bemade by processing data stored in the databases 25, 26 with predictivealgorithms, such as neural network-based programs and other computerprograms. In some cases, predictions can be made simply by processingtrends through human analysis, computer analysis, or a combination ofboth. In some cases, predictions may be processed by the internalprocessor 13 inside the wearable health module 21 (10).

Information from the health and environmental monitoring system 20 canbe used to track, direct, and predict the marketing, advertising,distribution, and sales of goods or services tailored towards one ormore subjects or groups in the monitoring system. As an example, trendsin high stress for a subject wearing a monitor 21 can be processed intoinformation relating the specific stress-related product needs, such asmedications, spas, or therapies, tailored for that specific subject.Similarly, trends in poor health may communicate corrective action tothe user, through the aforementioned wireless protocol, or throughmedical professionals to the user. In some cases, warnings may becommunicated to first responders to assist a subject. Information fromgroups of individuals in the monitoring system 20 may be used to track,direct, and predict the marketing, advertising, distribution, and salesof goods or services tailored towards a group or region.

Although many examples herein relate to generating profiles forindividuals or groups wearing monitors 21 in a monitoring system 20, itshould be understood that embodiments of the present invention havebroad applicability to users not wearing monitors 21. Profiles can begenerated for individuals not wearing monitors 21 based on similaritieswith one or more others who do wear monitors 21. Namely, individuals maybe targeted for advertisements, marketing, distribution, and sales forgoods and services based on a relationship with subjects wearingmonitors 21. For example, individuals matching the demographics of asubject or group of subjects being monitored in the monitoring system 20may received targeted ads, links, marketing, goods/services, and thelike. Additionally, users viewing information from the anonymousdatabase 26 may be subject to targeted or untargeted marketing and salesaspects, regardless of whether or not they wear a module 21.

The monitoring system 20 does not require subjects to wear monitors 21continuously to be functional. Subjects wearing modules 21 for merely afew minutes a day can provide useful information for the monitoringsystem 20 and for the individuals themselves.

An earpiece/headset form factor for a wearable sensor module 21 can beutilized for monitoring or predicting traffic-related conditions forautomobiles and other vehicles. As a specific example, a wearableearpiece module 21, containing physiological and environmental sensors,can provide information about the stress of a subject while driving, aswell as the speed of the subject, environmental conditions surroundingthe subject, alertness of the subject, and the like. This can beaccomplished by monitoring heart rate, breathing rate, core bodytemperature, acceleration, the weather conditions, air quality, and thelike with sensors 11, 12. Information from multiple subjects can be usedto track and study the stress of a group of individuals with certaintraffic-related conditions. Additionally, predictions about trafficjams, road accidents, traffic flow can be estimated based on processedinformation stored in the remote databases 25, 26. This information canalso be used to assist infrastructure decisions that will reduce thestress of drivers, improve traffic flow, and prevent automotiveaccidents. In some cases, this information may be used in studies tounderstand the interaction between stress, road conditions, environment,and the like.

In some embodiments, information from sensors in a sensor monitoringsystem 20 can be used to generate real-time maps related tophysiological and/or environmental conditions of groups of subjects overa geographical landscape. For example, a real-time health/stress map(see, for example, FIG. 12) or real-time air quality map can begenerated through a user interface 24 for informational or entertainmentvalue to one or more viewers. Aggregated data stored in the anonymousdatabase 26 can be processed into a map by correlating the location ofeach subject with physiological and environmental data measured bysensors 11, 12 integrated into a wearable monitor 21 worn by the eachsubject. Location information can be provided through the existingcellular infrastructure, through the triangulation of wireless signalsrelated to each subject, or through location sensors integrated into themonitor 21 or portable telecommunication device 22 (such as GPSsensors), or the like. These maps can be dynamic and real-time based onwireless updates from each subject. These maps can be local, regional,state-wide, national, world-wide, and the like.

Earpiece monitoring devices described herein need not be embodied withinheadsets only. For example, an wearable earpiece module 10 according toembodiments of the present invention can be a hearing aid, an earplug,an entertaining speaker, the earpiece for an IPOD®, Walkman®, or otherentertainment unit, a commercial headset for a phone operator, anearring, a gaming interface, or the like. A wearable earpiece module 10covers the broad realm of earpieces, ear jewelry, and ear apparatusesused by persons for entertainment, hearing, or other purposes bothinside and outside of health and environmental monitoring.

Moreover, two earpiece modules 10 may be utilized, according to someembodiments of the present invention; one for each ear of a person. Insome cases, dual-ear analysis can be performed with a single headsethaving dual earpieces. Dual-ear analysis with two earpiece modules canbe used, for example, to compare the core temperature of each tympanicmembrane in order to gauge brain activity comparing each brainhemisphere. In another case, acoustical energy, including ultrasonicenergy, can be passed from one earpiece module to the other, withacoustic absorption and reflection being used to gauge variousphysiological states. For example, this technique can be used to gaugehydration level in the head or brain by estimating the acoustical energyabsorption rate and sound velocity through the head of the user.

A variety of form factors for wearable monitoring devices 10 may be usedin the present invention. The form-factor of a wrist-watch, belt,article of clothing, necklace, ring, body piercing, bandage, electrode,headband, glasses or sunglasses, cast (i.e., for broken bones), toothfilling, etc. are but a few examples. A variety of earpiece styles,shapes, and architectures can be used for the case of where a wearablemonitoring device 10 is an earpiece module, according to embodiments ofthe present invention. A non-limiting embodiment of an earpiece moduleis illustrated in FIG. 4. The illustrated earpiece 40 fits over the earof a person and is held in place by an ear support 41 (also called the“earpiece attachment component” 15). The illustrated earpiece module 40also includes an earpiece body 42, an earpiece fitting 43, and anoptional earlobe clip 44. The earpiece may also contain an adjustablemouthpiece 52 (FIG. 5B) and/or a pinna cover 53 (FIGS. 5A-5B) describedbelow. The earpiece 40 connects with the ear canal of a person throughan earpiece fitting 43 located on the backside 45 of the earpiece 40.The earpiece fitting 43 transmits sound to the inner ear and eardrum.Health and environmental sensors are integrated primarily within oralong the earpiece body 42, including the earpiece backside 45. However,an earlobe clip 44 can contain various health and environmental sensorsas well. In some cases, health and environmental sensors can beintegrated within or along the ear support 41, the adjustable mouthpiece52, the earpiece fitting 43, or the pinna cover 53. Raw or processeddata 46 from these sensors can be wirelessly transferred to a recordingdevice or a portable telecommunication device 22 (FIG. 2). In someembodiments of the present invention, a recording device can be locatedwithin or about the earpiece 40 itself. In some cases, this recordingdevice is flash memory or other digitized memory storage. The types ofhealth and environmental factors which may be monitored have beenpreviously described above for the wearable monitoring device 10.

It should be understood that the earpiece body 42 can be any shape andsize suitable for wear around or near the ear. In some cases, theearpiece body and earpiece fitting can be one and the same structure,such that the earpiece body-fitting is a small fitting inside the ear.In many cases, it is desirable to seal off or partially seal off the earcanal so as to prevent sounds from entering or leaving the ear such thatauscultatory signal can more easily be extracted from the ear canalthrough devices (such as microphones) in the earpiece body-fitting.

It should be noted that the invention is not limited to the exemplaryearpiece 40 of FIG. 4. Other earpiece configurations are also capable ofintegrating health and environmental sensors for portable, noninvasive,real-time health monitoring according to embodiments of the presentinvention. For example, the earlobe clip can be modified to reach othersurfaces along or near a person's ear, head, neck, or face toaccommodate electrical or optical sensing. Similarly, more than one clipmay be integrated into the earpiece. Sensors can be integrated into theearpiece-fitting. In such embodiments, the sensors may be integratedinto a module in the earpiece-fitting. Environmental sensors arepreferably located on the outside of the earpiece through a region onthe earpiece frontside. This allows access to air in the vicinity of theearpiece user. However, environmental sensors can be located anywherealong the earpiece module 40.

FIGS. 5A-5B illustrate an embodiment of an earpiece module 50 with anadjustable mouthpiece 52 and a pinna cover 53. The earpiece 50 containsa region where an adjustable mouthpiece 52 can be swiveled, extended,pulled, extracted, flipped, or ejected towards the mouth. A microphoneat the end of the mouthpiece 52 can be used to improve personalcommunication through the earpiece 50. Sensors integrated into themouthpiece 52 can be used to monitor, for example, exhaled breath forrespirometry and inhalation/exhalation monitoring. Carbon dioxide,oxygen, nitrogen, water vapor, and other respired gases and vapors canbe monitored, providing an overall assessment of health. Additionally,VOC's and other vapors exhaled by the breath can be monitored fordiagnosing various disease states, such as diabetes, obesity, diet,metabolism, cancer, hepatic or renal health, organ functioning,alcoholism, halitosis, drug addiction, lung inflammation, voiceanalysis, voice distinction, and the like. The mouthpiece 52 is in aretracted or stored position in FIG. 5A and is in an extended oroperative position in FIG. 5B.

Another multifunctional earpiece module 60, according to embodiments ofthe present invention, is illustrated in FIG. 6. The illustratedearpiece module 60 includes the embodiments described with respect toFIGS. 4 and 5A-5B, such as a pinna cover 62, an ear support 63, amouthpiece 64, an earpiece body 65, and the like. Additionally, theearpiece module 60 may contain an extension 66 with sensors formonitoring jaw motion, arterial blood flow near the neck, or otherphysiological and environmental factors near the jaw and neck region.

The person illustrated in FIG. 6 is also wearing an earring monitor 67according to some embodiments of the present invention. Because at leastone portion of an earring may penetrate the skin, earring monitor 67 maycontain sensors and telemetric circuitry that provide access to variousblood analytes through iontophoresis and electrochemical sensing thatmay not be easily accessible by the other portions of the earpiecemodule 60. Additionally, the earring 67 may provide a good electricalcontact for ECG or skin conductivity.

Embodiments of the present invention are not limited to earpiecemodules. Other types of modules may be utilized that attach to otherportions of a person's body. For example, a temple module 70 having asimilar design as the earpiece module design 10 can also be employed, asillustrated in FIG. 7. A temple module 70 has the benefit of being closeto physiological areas associated with stress, intracranial pressure,brain activity, and migraines. Additionally, a temple module can monitorphysiological activity associated with the onset of a stroke, such asincreased or decreased blood flow and/or oxygen flow to the brain.

FIG. 8 illustrates a monitoring device 10, according to some embodimentsof the present invention, that is integrated into a telemetricBluetooth® module. Though a Bluetooth® module is illustrated, it shouldbe understood that other telemetric modules can be used. Telemetricmodules according to some embodiments of the present invention mayoperate in open architecture protocols, allowing multiple telemetricdevices to communicate with each other. A Bluetooth® module (includingthe monitoring device) according to some embodiments of the presentinvention is integrated into a wearable earpiece module (i.e.,monitoring device 10 described above). The monitoring device illustratedin FIG. 8 contains one or more sensors, and is mounted onto a Bluetooth®module. In one embodiment, the sensor module is directly soldered ontothe Bluetooth® module. In another embodiment, the sensor module iselevated from the Bluetooth® module with spacers, and a cable orelectrical wires connect between the sensor module and the Bluetooth®module. The module may be elevated in embodiments where the sensors needto be exposed to the environment. For example, the sensors may need tobe exposed through the frontside region of an earpiece module, and theBluetooth® module may fit too deeply into the earpiece module to providesensor access to the external environment. In some cases, contact leadsor vias may connect between the sensor module and an extended sensor oran additional sensor module. This allows the extended sensor or sensormodule to be flexibly mounted anywhere inside, along, outside, or aboutthe wearable sensor module 10. Extended sensors can be especially usefulfor 4-point galvanometric monitoring of skin conductance, pulseoximetry, and volatile organic compound monitoring.

Pulse oximetry is a standard noninvasive technique of estimating bloodgas levels. Pulse oximeters typically employ 2 or more opticalwavelengths to estimate the ratio of oxygenated to deoxygenated blood.Similarly, various types of hemoglobin, such as methemoglobin andcarboxyhemoglobin can be differentiated by measuring and comparing theoptical absorption at key red and near-infrared wavelengths. Additionalwavelengths can be incorporated and/or replace conventional wavelengths.For example, by adding additional visible and infrared wavelengths,myoglobin, methemoglobin, carboxyhemoglobin, bilirubin, SpCO2, and bloodurea nitrogen (BUN) can be estimated and/or monitored in real-time inaddition to the conventional pulse oximetry SpO2 measurement.

Blood hydration can also be monitored optically, as water selectivelyabsorbs optical wavelengths in the mid-IR and blue-UV ranges, whereaswater can be more transparent to the blue-green wavelengths. Thus, thesame optical emitter/detector configuration used in earpiece pulseoximetry can be employed for hydration monitoring. However, mid-IR orblue optical emitters and detectors may be required. Additionally,monitoring the ratio of blue-green to other transmitted or reflectedwavelengths may aid the real-time assessment of blood hydration levels.Blood hydration can also be monitored by measuring changes incapacitance, resistance, or inductance along the ear in response tovarying water content in the skin tissues or blood. Similarly, hydrationcan be estimated by monitoring ions extracted via iontophoresis acrossthe skin. Additionally, measuring the return velocity of reflected sound(including ultrasound) entering the head can be used to gauge hydration.These hydration sensors can be mounted anywhere within or along anearpiece or other monitoring device 10. It should be noted that otherhydration sensors can also be incorporated into a module.

A variety of techniques can be used for monitoring blood metabolites viaan earpiece module, such as wearable monitoring device 10. For example,glucose can be monitored via iontophoresis at the surface of the skincombined with enzyme detection. Blood urea nitrogen (BUN) can bemonitored by monitoring UV fluorescence in blood (through the skin) orby monitoring visible and mid-IR light absorption using the pulseoximetry approach described above. Various ions such as sodium,potassium, magnesium, calcium, iron, copper, nickel, and other metalions, can be monitored via selective electrodes in an earpiece modulefollowing iontophoresis through the skin.

Cardiopulmonary functioning can be evaluated by monitoring bloodpressure, pulse, cardiac output, and blood gas levels via earpiecemodules, and other monitoring apparatus in accordance with someembodiments of the present invention. Pulse rate and intensity can bemonitored through pulse oximetry (described above) as well as by sensingan increase in oxygenated blood with time. Pulse rate and blood flow mayalso be assessed through impedance measurements via galvanometry near ablood vessel. Additionally, pulse rate and blood flow may be assessedthrough a fast-response thermal energy sensor, such as a pyroelectricsensor. Because moving blood may temporarily increase or decrease thelocalized temperature near a blood vessel, a pyroelectric sensor willgenerate an electrical signal that is proportional to the total bloodflow in time.

Blood pressure can be monitored along an earlobe, for example. Accordingto some embodiments of the present invention, a digital blood pressuremeter is integrated into an earpiece module, such as earpiece 40 of FIG.4. A compact clip containing actuators and sonic and pressuretransducers, can be placed along the earlobe, and systolic and diastolicpressure can be measured by monitoring the pressure at which thewell-known Korotkoff sound is first heard (systolic), then disappears(diastolic). This technique can also be used to monitor intra-cranialpressure and other internal pressures. Blood pressure may also bemeasured by comparing the time between pulses at different regions ofthe body. For example, sensors for monitoring pulse rate and bloodvolume can be located in front of the ear and behind the ear or at theearlobe, and the time between the detection of each pulse from eachsensor, as well as the volume of blood passed, can be processed by asignal processor 13 into an indication of blood pressure.

Electrodes within or about an earpiece can also be utilized to monitorblood gases diffused through the skin, giving an indication of blood gasmetabolism. For example, a compact Severinghaus electrode can beincorporated within an earpiece module for the real-time monitoring ofCO2 levels in the blood, for example, through an earlobe connector, asensor region of an earpiece fitting, or along or about an ear support.These Severinghaus-type electrodes can also be used to monitor otherblood gases besides CO2, such as oxygen and nitrogen.

Organ function monitoring includes monitoring, for example, the liver,kidneys, pancreas, skin, and other vital or important organs. Liverquality can be monitored noninvasively by monitoring optical absorptionand reflection at various optical wavelengths. For example, opticalreflection from white LEDs or selected visible-wavelength LEDs can beused to monitor bilirubin levels in the skin and blood, for a real-timeassessment of liver health.

Monitoring neurological functioning can be accomplished via electrodesplaced at the ear, near the ear, or along another surface of the body.When such electrodes are placed along the forehead, this process isdescribed as electroencephalography, and the resulting data is called anelectroencephalogram (EEG). These electrodes can be either integratedinto an earpiece module or connected to an earpiece module, according tosome embodiments of the present invention. For example, an earlobe clip(e.g., 44, FIG. 4) can be modified to conform with EEG electrodes orother electrodes for measuring brain waves or neurological activity. Formonitoring neurological functioning, a temple earpiece (e.g., 70, FIG.7) may also be used. Electrodes may be positioned in a temple earpieceregion near the temples of a user for direct contact with the skin. Insome embodiments, direct contact is not necessary, and the neurologicalfunctioning can be monitored capacitively, inductively,electromagnetically, or a combination of these approaches. In someembodiments, brain waves may couple with low frequency acousticalsensors integrated into an earpiece module.

A person's body motion and head position can be monitored by integratinga motion sensor into an earpiece module (e.g., 40, FIG. 4) Two suchcompact motion sensors include gyroscopes and accelerometers, typicallymechanical or optical in origin. In some embodiments, an accelerometermay be composed of one or more microelectromechanical systems (MEMS)devices. In some embodiments, an accelerometer can measure accelerationor position in 2 or more axes. When the head is moved, a motion sensordetects the displaced motion from the origin. A head position monitorcan be used to sense convulsions or seizures and relay this informationwirelessly to a recording device. Similarly, head position monitoringmay serve as a feedback mechanism for exercise and athletic trainingwere head positioning with respect to the body is important.Additionally, the head position monitoring can be used to monitor whensomeone has fallen down or is not moving.

Body temperature, including core and skin temperature, can be monitoredin real-time by integrating compact infrared sensors into an earpiecemodule, according to some embodiments of the present invention. Infraredsensors are generally composed of thermoelectric/pyroelectric materialsor semiconductor devices, such as photodiodes or photoconductors.Thermistors, thermocouples, and other temperature-dependent transducerscan also be incorporated for monitoring body temperature. These sensorscan be very compact and thus can be integrated throughout an earpiecemodule. In some embodiments, these sensors may be mounted along thebackside of an earpiece body, as illustrated in FIG. 4, where theearpiece connects with the ear canal. Temperature sensors aimed at thetympanic membrane may be more accurate than sensors aimed in otherdirections.

In some embodiments of the present invention, a pedometer can beintegrated into an earpiece module to measure the number of steps walkedduring a day. Pedometers that can be integrated into an earpiece moduleinclude, but are not limited to, mechanical pedometers (usuallyimplementing a metallic ball or spring), microelectromechanical systems(MEMS) pedometers, inertial sensor pedometers, accelerometer-basedpedometers, accelerometry, gyroscopic pedometers, and the like.

In some embodiments of the present invention, a pedometer for anearpiece module employs an acoustic sensor for monitoring thecharacteristic sounds of footsteps channeled along the ear canal. Forexample, an acoustic sensor can be integrated into an earpiece housing(e.g., 42, FIG. 4) along the backside thereof (e.g., 45, FIG. 4) and/orwithin an earpiece fitting thereof. The sounds generated from footstepscan be detected and analyzed with a signal processor using a noisecancellation or signal extraction approach to identify footstep soundsin the midst of convoluting physiological noise. In this embodiment,digitized electrical signals from footstep sounds from outside the bodyare compared with digitized electrical signals from footstep soundstraveling through the body (and ear canal), and only the spectralfeatures associated with both types of digitized signals are amplified.This provides a new signal that contains cleaner information aboutfootsteps.

Breathing characteristics can be monitored in a manner similar to thatof acoustic pedometry (described above) via auscultatory signalextraction. In some embodiments, an acoustic sensor in an earpiecemodule is used to sense sounds associated with breathing. Signalprocessing algorithms are then used to extract breathing sounds fromother sounds and noise. This information is processed into a breathingmonitor, capable of monitoring, for example, the intensity, volume, andspeed of breathing. Another method of monitoring breathing is to employpressure transducers into an earpiece module. Changes in pressure insideor near the ear associated with breathing can be measured directly and,through signal processing, translated into a breathing monitor.Similarly, optical reflection sensors can be used to monitor pressure inor near the ear by monitoring physical changes in the skin or tissues inresponse to breathing. For monitoring the physical changes of thetympanic membrane in response to breathing, and hence ascertainingbreathing rate, an optical signal extraction approach may be employed.At least one color sensor, or colorimetric sensor, can be employed tomonitor changes in color associated with breathing and other healthfactors.

It should be noted that some embodiments of the present inventionincorporate health sensors that do not employ chemical or biologicalreagents for monitoring various health factors. This is because suchsensors have traditionally required larger instrumentation (not suitablefor portability) and/or disposable samplers (not acceptable to most endusers). However, sensors employing chemical or biological reagents maybe incorporated into earpiece modules, according to some embodiments ofthe present invention. For example, the diffusion of analyte through theskin can be monitored electrically or optically by selective binding toenzymes or antibodies contained in the health sensors integrated into anearpiece module. In some cases, iontophoresis, agitation, heat, orosmosis may be required to pull ions from the skin or blood into thesensor region for monitoring health factors. In some cases, theseanalytes may be tagged with markers for electromagnetic, electrical,nuclear, or magnetic detection.

Caloric intake, physical activity, and metabolism can be monitored usinga core temperature sensor, an accelerometer, a sound extractionmethodology, a pulse oximeter, a hydration sensor, and the like. Thesesensors can be used individually or in unison to assess overall caloricmetabolism and physical activity for purposes such as diet monitoring,exercise monitoring, athletic training, and the like. For example, asound extraction methodology can be used to extract sounds associatedwith swallowing, and this can give an indication of total food volumeconsumed. Additionally, a core temperature sensor, such as a thermopile,a pyroelectric sensor, a thermoelectric sensor, or a thermistor, or atympanic membrane extraction technique, can be used to assessmetabolism. In one case, the core temperature is compared with theoutdoor temperature, and an estimate of the heat loss from the body ismade, which is related to metabolism.

Environmental temperature can be monitored, for example, by thermistor,thermocouple, diode junction drop reference, or the like. Electricaltemperature measurement techniques are well known to those skilled inthe art, and are of suitable size and power consumption that they can beintegrated into a wireless earpiece module without significant impact onthe size or functionality of the wireless earpiece module.

Environmental noise can be monitored, for example, by transducer,microphone, or the like. Monitoring of environmental noise preferablyincludes, but is not limited to, instantaneous intensity, spectralfrequency, repetition frequency, peak intensity, commonly in units ofdecibels, and cumulative noise level exposures, commonly in units ofdecibel-hours. This environmental noise may or may not include noisegenerated by a person wearing an earpiece module. Sound made by a personwearing an earpiece module may be filtered out, for example, usinganalog or digital noise cancellation techniques, by directionalmicrophone head shaping, or the like. The environmental noise sensor mayor may not be the same sensor as that used for the intended purpose ofwireless communication. In some embodiments, the environmental noisesensor is a separate sensor having broader audible detection range ofnoise level and frequency, at the possible sacrifice of audio quality.

Environmental smog includes VOC's, formaldehyde, alkenes, nitric oxide,PAH's, sulfur dioxide, carbon monoxide, olefins, aromatic compounds,xylene compounds, and the like. Monitoring of the aforementioned smogcomponents can be performed using earpiece modules and other wearableapparatus, according to some embodiments of the present invention, andin a variety of methods. All smog components may be monitored.Alternatively, single smog components or combinations of smog componentsmay be monitored. Photoionization detectors (PID's) may be used toprovide continuous monitoring and instantaneous readings. Other methodsof detecting smog components according to embodiments of the presentinvention include, but are not limited to, electrocatalytic,photocatalytic, photoelectrocatalytic, colorimetric, spectroscopic orchemical reaction methods. Examples of monitoring techniques using theaforementioned methods may include, but are not limited to, IR laserabsorption spectroscopy, difference frequency generation laserspectroscopy, porous silicon optical microcavities, surface plasmonresonance, absorptive polymers, absorptive dielectrics, and colorimetricsensors. For example, absorptive polymer capacitors inductors, or otherabsorptive polymer-based electronics can be incorporated into anearpiece module (e.g., 10, FIG. 1) according to embodiments of thepresent invention. These polymers change size or electrical or opticalproperties in response to analyte(s) from the environment (such as thosedescribed above). The electrical signal from these absorptive polymerelectronic sensors can be correlated with the type and intensity ofenvironmental analyte. Other techniques or combinations of techniquesmay also be employed to monitor smog components. For example, a smogcomponent may be monitored in addition to a reference, such as oxygen,nitrogen, hydrogen, or the like. Simultaneous monitoring of smogcomponents with a reference analyte of known concentration allows forcalibration of the estimated concentration of the smog component withrespect to the reference analyte within the vicinity of an earpieceuser.

In some embodiments of the present invention, environmental airparticles can be monitored with a flow cell and a particle counter,particle sizer, particle identifier, or other particulate matter sensorincorporated as part of an earpiece module (e.g., 10, FIG. 1) orexternally attached to an earpiece module. Non-limiting examples ofparticles include oil, metal shavings, dust, smoke, ash, mold, or otherbiological contaminates such as pollen. In some embodiments of thepresent invention, a sensor for monitoring particle size andconcentration is an optical particle counter. A light source is used(e.g., a laser or a laser diode), to illuminate a stream of air flow.However, a directional LED beam, generated by a resonant cavity LED(RCLED), a specially lensed LED, or an intense LED point source, canalso be used for particle detection. The optical detector which isoff-axis from the light beam measures the amount of light scattered froma single particle by refraction and diffraction. Both the size and thenumber of particles can be measured at the same time. The size of themonitored particle is estimated by the intensity of the scattered light.Additionally, particles can be detected by ionization detection, as witha commercial ionization smoke detector. In this case, a low-levelnuclear radiation source, such as americium-241, may be used to ionizeparticles in the air between two electrodes, and the total ionizedcharge is detected between the electrodes. As a further example,piezoelectric crystals and piezoelectric resonator devices can be usedto monitor particles in that particles reaching the piezoelectricsurface change the mass and hence frequency of electromechanicalresonance, and this can be correlated with particle mass. If theresonators are coated with selective coatings, certain types ofparticles can attach preferentially to the resonator, facilitating theidentification of certain types of particles in the air near a personwearing an earpiece module. In some embodiments, these resonators aresolid state electrical devices, such as MEMS devices, thin film bulkacoustic resonators (FBARs), surface-acoustic wave (SAW) devices, or thelike. These compact solid state components may be arrayed, each arrayedelement having a different selective coating, for monitoring varioustypes of particles.

In some embodiments of the present invention, environmental air pressureor barometric pressure can be monitored by a barometer. Non-limitingexamples of barometric pressure measurement include hydrostatic columnsusing mercury, water, or the like, foil-based or semiconductor-basedstrain gauge, pressure transducers, or the like. In some embodiments ofthe present invention, semiconductor-based strain gauges are utilized. Astrain gauge may utilize a piezoresistive material that gives anelectrical response that is indicative of the amount of deflection orstrain due to atmospheric pressure. Atmospheric pressure shows a diurnalcycle caused by global atmospheric tides. Environmental atmosphericpressure is of interest for prediction of weather and climate changes.Environmental pressure may also be used in conjunction with othersensing elements, such as temperature and humidity to calculate otherenvironmental factors, such as dew point. Air pressure can also bemeasured by a compact MEMS device composed of a microscale diaphragm,where the diaphragm is displaced under differential pressure and thisstrain is monitored by the piezoelectric or piezoresistive effect.

In some embodiments of the present invention, environmental humidity,relative humidity, and dew point can be monitored by measuringcapacitance, resistivity or thermal conductivity of materials exposed tothe air, or by spectroscopy changes in the air itself. Resistivehumidity sensors measure the change in electrical impedance of ahygroscopic medium such as a conductive polymer, salt, or treatedsubstrate. Capacitive humidity sensors utilize incremental change in thedielectric constant of a dielectric, which is nearly directlyproportional to the relative humidity of the surrounding environment.Thermal humidity sensors measure the absolute humidity by quantifyingthe difference between the thermal conductivity of dry air and that ofair containing water vapor. Humidity data can be stored along withpressure monitor data, and a simple algorithm can be used to extrapolatethe dew point. In some embodiments of the present invention, monitoringhumidity is performed via spectroscopy. The absorption of light by watermolecules in air is well known to those skilled in the art. The amountof absorption at known wavelengths is indicative of the humidity orrelative humidity. Humidity may be monitored with a spectroscopic methodthat is compatible with the smog monitoring spectroscopic methoddescribed above.

When environmental factors such as the aforementioned are monitoredcontinuously in real-time, a user's total exposure level to anenvironmental factor can be recorded. When a representative volume ofair a user has been exposed to is monitored or estimated, the volumetricconcentration of the analytes can be calculated or estimated. In orderto estimate the volume of air a person wearing an earpiece has beenexposed to, a pedometer or accelerometer or air flow sensor can also beintegrated into an earpiece module. Pedometers and accelerometers can beintegrated into an earpiece module via mechanical sensors (usuallyimplementing a mechanical-electrical switch), MEMS devices, and/orgyroscopic technologies. The technologies required for these types ofpedometers and accelerators are well known to those skilled in the art.The incorporated pedometer or accelerometer (or more than one pedometeror accelerometer) is used to gage the distance a person has traveled,for use in the estimation of the volume of air to which a person hasbeen exposed, and the subsequent estimate of the volumetricconcentration of monitored analytes.

The health and environmental sensors utilized with earpiece modules andother wearable monitoring apparatus, according to embodiments of thepresent invention, can operate through a user-selectable switch on anearpiece module. However, health and environmental sensors can also berun automatically and independently of the person wearing the apparatus.In other embodiments, the person may control health and environmentalmonitoring through a device wirelessly coupled to an earpiece module,such as a portable telecommunication device. For example, health andenvironmental sensors in or about an earpiece module can be controlledwirelessly through, for example, a cell phone, laptop, or personaldigital assistant (PDA).

A wearable monitoring device 10 may be configured such that userpreferences can be “downloaded” wirelessly without requiring changes tothe earpiece monitor hardware. For example, an earpiece concerned abouta heart condition may wish to have the signal processor 13 focus onprocessing pulse signature, at the expense of ignoring otherphysiological or environmental parameters. The user may then use theportable telecommunication device 22 to download a specialized algorithmthrough the web. This may be accomplished through existing wirelessinfrastructure by text-messaging to a database containing the algorithm.The user will then have an earpiece module suited with analysis softwarespecialized to the needs and desires of the user.

Health and environmental monitors, according to embodiments of thepresent invention, enable low-cost, real-time personal health andenvironmental exposure assessment monitoring of various health factors.An individual's health and environmental exposure record can be providedthroughout the day, week, month, or the like. Moreover, because thehealth and environmental sensors can be small and compact, the overallsize of an apparatus, such as an earpiece, can remain lightweight andcompact.

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. The invention is defined by the following claims, withequivalents of the claims to be included therein.

1. A method of monitoring a subject exposed to a marketing effort, themethod comprising: obtaining physiological information from the subjectvia at least one physiological sensor associated with a monitoringdevice attached to the subject, wherein the physiological informationcomprises one or more of the following: pulse rate information, bodytemperature information, breathing rate information, blood pressureinformation, cardiac output information, and blood gas levelinformation; obtaining subject motion information via at least onemotion sensor associated with the monitoring device; processing thesubject motion information via at least one processor to identifyfootstep information, body motion information, head motion information,jaw motion information, or swallowing information; and analyzing theprocessed physiological information in context with the identified typeof motion via at least one processor to assess the subject's response tothe marketing effort.
 2. The method of claim 1, wherein the monitoringdevice includes at least one transmitter and further comprisingtransmitting the physiological information and motion information to adevice remotely located from the subject via the at least onetransmitter.
 3. The method of claim 1, wherein analyzing the processedphysiological information in context with the identified type of motioncomprises determining a stress level of the subject.
 4. The method ofclaim 1, further comprising processing the obtained physiologicalinformation, via at least one processor, into signals that can be heardand/or viewed by the subject.
 5. The method of claim 1, wherein the atleast one motion sensor is an accelerometer, an acoustic sensor, a MEMSmotion sensor, or a gyroscope.
 6. The method of claim 1, wherein theportable monitoring device is an earpiece module.
 7. The method of claim1, further comprising processing the obtained physiological informationvia at least one processor to remove corrupted signals associated withthe subject motion information from the physiological information. 8.The method of claim 1, wherein at least one processor is associated withthe monitoring device.
 9. The method of claim 1, wherein at least oneprocessor is associated with a device remote from the monitoring device.10. A method of monitoring efficacy of a medical treatment of a subject,the method comprising: obtaining physiological information from thesubject via at least one physiological sensor associated with amonitoring device attached to the subject, wherein the physiologicalinformation comprises one or more of the following: pulse rateinformation, body temperature information, breathing rate information,blood pressure information, cardiac output information, and blood gaslevel information; obtaining subject motion information via at least onemotion sensor associated with the monitoring device; processing thesubject motion information via at least one processor to identifyfootstep information, body motion information, head motion information,jaw motion information, or swallowing information; and analyzing theprocessed physiological information in context with the identified typeof motion via at least one processor to assess the subject's response tothe medical treatment.
 11. The method of claim 10, wherein the medicaltreatment is a drug taken by the subject.
 12. The method of claim 11,wherein the monitoring device includes a dosimeter, and furthercomprising monitoring an amount of the drug taken by the subject via thedosimeter.
 13. The method of claim 10, wherein the medical treatment isphysical therapy taken by the subject.
 14. The method of claim 10,wherein the medical treatment is a medical device used by the subject.15. The method of claim 10, wherein the monitoring device includes atleast one transmitter and further comprising transmitting thephysiological information and motion information to a device remotelylocated from the subject via the at least one transmitter.
 16. Themethod of claim 10, wherein analyzing the processed physiologicalinformation in context with the identified type of motion comprisesdetermining a stress level of the subject.
 17. The method of claim 10,further comprising processing the obtained physiological information,via at least one processor, into signals that can be heard and/or viewedby the subject.
 18. The method of claim 10, further comprisingcommunicating corrective action information to the subject, via at leastone processor.
 19. The method of claim 10, wherein the at least onemotion sensor is an accelerometer, an acoustic sensor, a MEMS motionsensor, or a gyroscope.
 20. The method of claim 10, wherein the portablemonitoring device is an earpiece module.
 21. The method of claim 10,further comprising processing the obtained physiological information viaat least one processor to remove corrupted signals associated with thesubject motion information from the physiological information.
 22. Themethod of claim 10, wherein at least one processor is associated withthe monitoring device.
 23. The method of claim 10, wherein at least oneprocessor is associated with a device remote from the monitoring device.24. A method of monitoring efficacy of a medical treatment of a subject,the method comprising: obtaining physiological information from thesubject via at least one physiological sensor associated with amonitoring device attached to the subject, wherein the physiologicalinformation comprises one or more of the following: pulse rateinformation, body temperature information, breathing rate information,blood pressure information, cardiac output information, and blood gaslevel information; obtaining environmental condition information in thevicinity of the subject via at least one environmental sensor associatedwith the monitoring device, wherein the environmental conditioninformation comprises one or more of the following: volatile organiccompounds (VOCs), pollution, noise, light, and temperature; obtainingsubject motion information via at least one motion sensor associatedwith the monitoring device; processing the subject motion informationvia at least one processor to identify footstep information, body motioninformation, head motion information, jaw motion information, orswallowing information; and analyzing the processed physiologicalinformation and environmental condition information in context with theidentified type of motion via at least one processor to assess thesubject's response to the medical treatment.
 25. The method of claim 24,wherein the medical treatment is a drug taken by the subject.
 26. Themethod of claim 25, wherein the monitoring device includes a dosimeter,and further comprising monitoring an amount of the drug taken by thesubject via the dosimeter.
 27. The method of claim 24, wherein themedical treatment is physical therapy taken by the subject.
 28. Themethod of claim 24, wherein the medical treatment is a medical deviceused by the subject.
 29. The method of claim 24, further comprisingtransmitting the processed physiological information to a deviceremotely located from the subject via the at least one transmitter. 30.The method of claim 24, wherein analyzing the processed physiologicalinformation in context with the identified type of motion comprisesdetermining a stress level of the subject.
 31. The method of claim 24,further comprising processing the obtained physiological information,via at least one processor, into signals that can be heard and/or viewedby the subject.
 32. The method of claim 24, further comprisingcommunicating corrective action information to the subject, via at leastone processor.
 33. The method of claim 24, wherein the at least onemotion sensor is an accelerometer, an acoustic sensor, a MEMS motionsensor, or a gyroscope.
 34. The method of claim 24, wherein the portablemonitoring device is an earpiece module.
 35. The method of claim 24,further comprising processing the obtained physiological information andenvironmental condition information via at least one processor to removecorrupted signals associated with the subject motion from thephysiological information and environmental condition information. 36.The method of claim 24, wherein the at least one processor is associatedwith the monitoring device.
 37. The method of claim 24, wherein the atleast one processor is associated with a device remote from themonitoring device.
 38. A method of monitoring a plurality of subjects,wherein a monitoring device is attached to each of the subjects, whereineach monitoring device includes at least one physiological sensor, andat least one motion sensor, the method comprising: obtainingphysiological information from each subject via a respective monitoringdevice physiological sensor, wherein the physiological informationcomprises one or more of the following: pulse rate information, bodytemperature information, breathing rate information, blood pressureinformation, cardiac output information, and blood gas levelinformation; obtaining subject motion information from each subject viaa respective monitoring device motion sensor; processing the subjectmotion information to identify footstep information, body motioninformation, head motion information, jaw motion information, orswallowing information; and using the processed physiologicalinformation in context with the identified type of motion for each ofthe subjects to generate at least one statistical relationship.
 39. Themethod of claim 38, wherein the at least one statistical relationshipcomprises an average value of one of pulse rate information, bodytemperature information, breathing rate information, blood pressureinformation, cardiac output information, and blood gas level informationfor the plurality of subjects.
 40. The method of claim 38, wherein theat least one statistical relationship comprises a statisticalrelationship between one of body temperature information, breathing rateinformation, blood pressure information, cardiac output information, andblood gas level information for a particular subject and an averagevalue of a corresponding one of pulse rate information, body temperatureinformation, breathing rate information, blood pressure information,cardiac output information, and blood gas level information for theplurality of subjects.
 41. The method of claim 38, wherein the at leastone statistical relationship comprises a statistical relationshipbetween one of body temperature information, breathing rate information,blood pressure information, cardiac output information, and blood gaslevel information for a particular subject and subject motioninformation for the particular subject
 42. The method of claim 38,wherein the statistical relationship comprises an average value ofphysiological information for the plurality of subjects.
 43. The methodof claim 38, further comprising, for each subject, processing theobtained physiological information to remove corrupted signalsassociated with the subject motion information from the physiologicalinformation.
 44. A method of monitoring a plurality of subjects, whereina monitoring device is attached to each of the subjects, wherein eachmonitoring device includes at least one environmental sensor, and atleast one motion sensor, the method comprising: obtaining environmentalinformation from each subject via a respective monitoring deviceenvironmental sensor, wherein the environmental condition informationcomprises one or more of the following: volatile organic compounds(VOCs), pollution, noise, light, and temperature; obtaining subjectmotion information from each subject via a respective monitoring devicemotion sensor; processing the subject motion information to identifyfootstep information, body motion information, head motion information,jaw motion information, or swallowing information; and using theprocessed environmental information in context with the identified typeof motion for each of the subjects to generate at least one statisticalrelationship.
 45. The method of claim 44, wherein the at least onestatistical relationship comprises an average value of one of volatileorganic compounds (VOCs), pollution, noise, light, and temperature forthe plurality of subjects.
 46. The method of claim 44, wherein the atleast one statistical relationship comprises a statistical relationshipbetween one of volatile organic compounds (VOCs), pollution, noise,light, and temperature in a vicinity of a particular subject and anaverage value of a corresponding one of volatile organic compounds(VOCs), pollution, noise, light, and temperature for the plurality ofsubjects.
 47. The method of claim 44, wherein the at least onestatistical relationship comprises a statistical relationship betweenone of volatile organic compounds (VOCs), pollution, noise, light, andtemperature for a particular subject and subject motion information forthe particular subject
 48. The method of claim 44, further comprisingprocessing the obtained environmental information to remove corruptedsignals associated with the subject motion information from theenvironmental information.